Conformity assessment of custom-made medical devices with the requirements of the Technical Regulation

On December 1, 2023, Cratia together with the Association of market operators of medical devices (AMOMD^®) organized the first educational webinar on the regulation of assistive devices for rehabilitation and 3D printing of medical devices in Ukraine.

This webinar became a significant event in technical regulation for the medical field, focusing on providing assistive devices for rehabilitation (technical and other means of rehabilitation) for persons with disabilities, children with disabilities, and other specific groups of people.

The webinar brought together key market operators regarding assistive devices for rehabilitation and served as a platform for dialogue with the Ministry of Health, the Ministry of Social Policy, the State Service of Ukraine on Medicines and Drugs Control, and the Social Protection Fund for persons with disabilities.

Speakers from central executive authorities extensively discussed the regulation of custom-made medical devices, addressed current requirements, and outlined future plans.

Maksym Bagrieiev, managing partner of Cratia, discussed the procedure for assessing the conformity of custom-made medical devices.

Maksym emphasized that such a procedure is applied by manufacturers of assistive devices for rehabilitation, such as prostheses, orthoses, orthopedic footwear, and cushions for bedsores, as well as by manufacturers in dental laboratories producing products for individual patients based on a dentist’s prescription.

As known, many manufacturers are currently listed in the e-register of the State Service of Ukraine on Medicines and Drugs Control, yet they urgently require documentation development in compliance with legislative requirements for medical devices.

Cratia develops technical documentation (technical files) for medical devices and implements quality management systems in medical device manufacturing enterprises. Considering the high demand for custom-made medical devices and numerous changes in requirements and regulations, manufacturers face a critical need for developing technical documentation. At this stage, it is crucial to avoid errors as it concerns the lives and health of the people. Therefore, documentation must be prepared correctly from the outset to comply with all regulatory requirements. For most manufacturers, these requirements are new, but this does not exempt them from responsibility according to Ukrainian legislation on health protection.

The first thing to pay attention to, as Maksym pointed out, is whether the product qualifies as a medical device. This question is important because only by answering it can one understand if an assessment of conformity to technical regulations is required, and which legislation will be applicable to the product during its manufacture, installation, etc. What is the legal status of the enterprise: manufacturer, importer, or healthcare institution? This is also a crucial question as different requirements apply to a manufacturer compared to an importer or healthcare institution. Although in some cases, the activities of a manufacturer and a healthcare institution may be very similar.

What is the difference between medical devices and custom-made medical devices? The same product can be classified differently, and this can change the applicable legislative requirements. For instance, metal plates and screws for osteosynthesis manufactured in series and those custom-made undergo entirely different conformity assessment procedures. Series-produced screws and plates undergo the most complex procedure because they belong to a high-risk class of medical devices, requiring the involvement of a conformity assessment body in the assessment process. This procedure requires an audit or, for a foreign manufacturer, possible recognition of its EC certificate. However, in any case, a conformity assessment body is involved, making the procedure very complex. If plates and screws are considered custom-made products, on the contrary, the conformity assessment procedure can be relatively straightforward, as it needs to comply with Annex 9 of Technical Regulation No. 753 (TR 753).

Quite often, custom-made medical devices are composed of different components, such as stump sockets, knee units, ankle adapters, trim modules, feet, and so on. If a medical device is custom-made, the design, production, assembly, and configuration activities constitute a manufacturing process, and the entity involved is considered a manufacturer. However, if the product is a mass-produced medical device, with unchanged specifications, purposes, and intended use, it does not fall under the manufacturing category, and the entity is not considered a manufacturer. Such an entity may have the status of a distributor, a seller who introduces the medical device into circulation or use, or a healthcare institution that makes minor modifications to the medical device to tailor it to the needs of a specific patient.

Therefore, concerning custom-made medical devices, these products undergo conformity assessment according to Annex 9 of TR 753. All other products undergo conformity assessment through different annexes.

The term “custom-made medical device” clarifies and expands on the concept of a medical device. Specifically, it refers to a product specifically manufactured as per a written prescription from a physician or a qualified professional who determines the specific design characteristics of this medical device solely for a particular consumer. In contrast, a mass-produced medical device altered to meet the individual needs of a healthcare practitioner or any other professional user is not considered a custom-made medical device.

From a practical standpoint, a custom-made medical device is a product manufactured explicitly following a written prescription. This prescription provides specific constructional characteristics for the product, exclusively intended for a specific patient. Only under these conditions is the product considered custom-made. Such a prescription may lead to an entirely new design of the medical device when a physician or a qualified individual issues it, prompting the manufacturer to design the product from scratch or significantly modify the design from a previous patient’s device.

Custom-made medical devices include systems for spinal orthoses, upper limb orthoses, lower limb orthoses, upper limb prosthetic systems, lower limb prosthetic systems, or breast prostheses – obviously tailored for a specific individual patient. Custom orthopedic footwear is a custom-made product when designed for a specific patient. Similarly, individual care and protection aids, individually made implants, membranes, and plates, such as those for osteosynthesis, are considered custom-made if specifically manufactured for a particular patient. Therefore, most products from dental laboratories, including crowns, implants, caps, structures, and aligners, are usually designed for a specific patient and fall under custom-made products.

However, products like spectacle frames and lenses assembled to form glasses are not custom-made. Adjustable wheelchairs, essentially adaptable to different patients, are not individualized and may be adapted to other patients. Dental cements, and implants used in dentistry, even if mixed before a procedure, do not qualify as custom-made products. Their mixing was anticipated by the manufacturer. Series-produced plates for osteosynthesis, and endoprostheses, are not custom-made products either. Additionally, mass-produced orthopedic footwear is not individualized and does not qualify as a custom-made product.

Next, Maksym drew attention to rehabilitation aids. According to changes in Article 26 of the Law of Ukraine “On Rehabilitation of Persons with Disabilities in Ukraine”, rehabilitation aids fall under the scope of technical regulations regarding medical devices. Thus, the Law fully transfers rehabilitation aids into the category of “medical devices”. However, it is understood that medical devices vary: there are mass-produced medical devices and custom-made devices.

According to clause 5 of the Cabinet of Ministers Resolution No. 321 “On Approval of the Procedure for Providing rehabilitation aids (Technical and Other Rehabilitation Means) to Persons with Disabilities, Children with Disabilities, and Other Separate Categories of the Population and Payment of Cash Compensation for Independently Purchased Such Means from the List”, rehabilitation aids intended for the free provision to individuals must be included by the State Service of Ukraine on Medicines and Drugs Control to the Register of entities responsible for introducing active medical devices that are implanted and in vitro diagnostic medical devices into circulation. When a manufacturer registers their product in this register, it automatically implies that the said product is a medical device and therefore must comply with established requirements at the time of inclusion in the register.

According to the Ministry of Health Order No. 142 “On Approval of Methodological Recommendations for the Application of the Technical Regulation on medical devices”, custom-made products such as prostheses, and individual hearing aids are mostly considered products for individual use. Before introducing a custom-made medical device into circulation, the manufacturer must follow the procedure specified in Annex 9 of TR 753 and prepare an application. In these cases, intermediate products specifically intended for the production of custom-made medical devices are recommended to be considered medical devices. This largely applies to dental alloys, modular components for prosthetics, if the use of such products is directly related to medical devices.

Therefore, products that serve as constituent components or assemblies or even raw materials for the manufacturer are recommended to be considered medical devices that undergo their conformity assessment according to the Technical Regulation.

If constituent components and assemblies are medical devices and have undergone conformity assessment with declarations of conformity, test reports, etc., then manufacturers of medical devices made from these components receive certain simplifications during the development of their technical files. Accordingly, it is recommended to inquire with suppliers whether they have undergone conformity assessment procedures and possess technical documentation.

In his report, Maksym provided an analysis of the list of products specified in the appendices to Resolution No. 321 and distributed rehabilitation aids, technical, and other means provided to individuals with disabilities and other categories of people.

Thus, attendees were immediately able to familiarize themselves with which products from the list are custom-made and which are medical devices.

The conformity assessment procedure according to Annex 9 of TR 753 requires the manufacturer to prepare an application for a custom-made device, which should be prepared for each specific patient. However, the manufacturer is not obliged to register each application with the State Service of Ukraine on Medicines and Drugs Control. Nevertheless, they must retain this application and create technical documentation while maintaining a quality management system.

Medical devices that are not custom-made undergo conformity assessment according to a different Annex. Typically, medical devices listed in Resolution No. 321 fall under Class I medical devices, thus undergoing conformity assessment according to Annex 8 of TR 753. Such medical devices also have a technical file, and the manufacturer must have a quality management system confirming compliance with the requirements of TR 753. Specifically, a checklist of the main requirements must be compiled, confirming that the medical devices meet the essential requirements of Annex 1 of TR 753.

Medical devices of risk classes Is, Im, IIa, IIb, and III undergo a procedure with mandatory involvement of a conformity assessment body. The conformity assessment body is an organization accredited and designated by the Ministry of Economy to perform such functions. Essentially, it is a third party that evaluates the documentation and, in most cases, conducts an audit. However, for Class I medical devices and custom-made medical devices, the involvement of such a third party is not required.

As a result, Annex 9 of TR 753 requires the compilation of an application, along with confirmation that the respective medical device complies with the essential requirements set out in Annex 1 according to paragraph 11 of TR 753. This requirement generally applies to all medical devices and is specifically reiterated in Annex 9 of TR 753.

The list of essential requirements in Annex 1 of TR 753 consists of 47 points. These requirements for medical devices are divided into several sections, each containing several points outlining the requirements that the manufacturer must fulfill.

For instance, the first requirement stipulates that medical devices must be designed and manufactured in such a way that, when used for their intended purpose, they do not pose risks to the clinical condition. This means that the manufacturer must confirm this by having a quality management system in production.

The second point also requires a quality management system, and the third involves informing users about the potential risks of using medical devices. Additionally, there are requirements regarding the information on the operational characteristics of the device, risk mitigation or elimination information, and clinical evaluation. There are further demands concerning material biocompatibility, material selection, quality management systems, and risk analysis.

Maksym also demonstrated how the confirmation of these essential requirements occurs and provided an example of a checklist for compliance with Annex 1 of TR 753. The checklist allows the manufacturer to verify whether all relevant requirements of Annex 1 of TR 753 have been met and whether anything else needs confirmation. Moreover, during market surveillance, particularly during inspections, the State Service of Ukraine on Medicines and Drugs Control requests the checklist as one of the first documents.

By analyzing each requirement of Annex 1 of TR 753, a list of documents required to confirm these requirements can be compiled. The technical documentation for medical devices serves as confirmation of compliance with the requirements of Annex 1 of TR 753.

When a manufacturer declares the use of standards, they must have reports confirming compliance with such standards and, consequently, TR requirements. The utilization of standards allows for achieving compliance with the requirements of TR 753, as certain standards provide a presumption of conformity.

Medical devices must have risk analysis results, descriptions of sterilization methods if the products are sterile, and obligatory results of the preclinical (biological) evaluation, namely biocompatibility, as materials interacting with the human body can transfer toxic or carcinogenic substances from the material to the human body. Additionally, clinical evaluation results according to Annex 10 to TR 753, labeling, instructions for use, a checklist of essential requirements, and compiled statements for each custom-made medical device are mandatory.

The manufacturer must review and document the experience accumulated after introducing medical devices into circulation. The manufacturer should possess a system, specifically a quality management system, to monitor and gather information about medical devices. Other requirements involve notifications to the State Service of Ukraine on Medicines and Drugs Control regarding serious incidents or reasons for systematic product recalls. Therefore, the manufacturer must report any malfunction or deterioration that leads to consumer death or significant health deterioration.

The use of standards is voluntary; however, paragraph 9 of Technical Regulation 753 states that medical devices complying with requirements of national standards included in the list of national standards conforming to European harmonized standards, and whose voluntary application can be perceived as evidence of compliance. The manufacturer must verify which specific standards are applied to the device and use them as evidence of conformity. For example, compliance with biological assessment requirements can be validated by employing the ISO 10993 series of standards.

Regarding the quality management system, ISO 13485 is currently the sole standard for the quality management system, providing a presumption of conformity.

The standards can be found in the Order of the Ministry of Health No. 1245 “On approval of the list of national standards, compliance with which provides a presumption of conformity of medical devices with the requirements of the Technical Regulation on medical devices”, particularly those specialized for prosthetics, orthotics, and the like.

Concerning the labeling of medical devices, in addition to general requirements for custom-made products, specific wording such as “custom-made medical device” must be included. It is necessary to develop documents for the production quality management system and technical documentation for medical devices, create a checklist, submit information to the electronic register of persons responsible for the placing medical devices on the market, prepare statements for each medical device, keep them for at least 5 years, and conduct post-market surveillance. The State Service of Ukraine on Medicines and Drugs Control conducts an examination of the information submitted to the register or may refuse registration for specific reasons, such as doubts regarding the classification of the product as a medical device or a custom-made product.

To conclude, Maksym shared the extensive practical experience of Cratia regarding market surveillance. The checks conducted by the State Service of Ukraine on Medicines and Drugs Control can be both scheduled and unscheduled, including on-site and off-site inspections.

In addition to being the state body responsible for market surveillance of medical devices, the State Service of Ukraine on Medicines and Drugs Control (Market Surveillance Authority in Ukraine) also inspects healthcare institutions to ensure compliance with licensing requirements. They also inspect pharmacies and other places where medical devices are sold. Therefore, during an inspection of a healthcare facility, the State Service of Ukraine on Medicines and Drugs Control may access their inventory, review shelf contents, and inspect equipment and related documentation.

Moreover, consumers can file complaints with the State Service of Ukraine on Medicines and Drugs Control, and even competitors can submit complaints regarding a competitor’s products. In such cases, the State Service of Ukraine on Medicines and Drugs Control may conduct an unscheduled inspection. The manufacturer or its authorized representative (if the manufacturer is a non-resident) receives a notification about the unscheduled inspection only within 10 working days. Therefore, preparing and developing technical documentation within such a timeframe is practically impossible.

If there are non-conformities with requirements or missing documents, the State Service of Ukraine on Medicines and Drugs Control applies restrictive and corrective measures. Specifically, these actions include restricting the product’s placement on the market, prohibiting the distribution of the product, withdrawing it from circulation, or recalling such products. The minimum fine is 51,000 UAH for the first violation, while repeated fines amount to 102,000 UAH. Importantly, fines are imposed for each model, SKU, or batch of products deemed unsafe or non-compliant.

The next speaker was Viktoriia Moroz, a Key Account Manager at Cratia, who presented a report dedicated to the quality management system in the production of custom-made medical devices.

Viktoriia emphasized that the quality management system should be viewed as a tool to improve the safety and quality of medical products.

The Quality Management System (QMS) is a set of interconnected and interacting elements aimed at achieving quality objectives. It comprises an organizational structure, planning, processes, resources, and documents used to achieve quality goals.

When it comes to medical devices, one of the main goals is compliance with regulatory requirements. Additionally, it is essential to consider customers’ needs and their requirements to ensure product quality and innovation. Therefore, having an effective Quality Management System, the manufacturer consistently improves their production and quality.

For the QMS to function properly, senior management must be involved in implementing and maintaining the QMS. Since the highest management knows the company’s direction, scale, or prospects in product distribution. Additionally, top management must set specific measurable quality goals.

ISO 13485 is an industry-standard applied to the production of medical devices. This standard provides a presumption of conformity to requirements. Thus, by using this standard, a manufacturer can confirm the compliance of its Quality Management System with legislation, particularly Technical Regulation 753.

It is necessary to document the Quality Management System to demonstrate compliance. The implementation of the QMS must not become bureaucratic or entail excessive paperwork. The costs associated with implementing QMS should be seen as investments in improvement and the company’s ability to meet user needs and legislative requirements.

Understanding who needs a Quality Management System in production and the advantages it creates is key. Essentially, all employees of the company are involved in the system: from the owner to department managers and employees.

For business owners or managers, QMS allows for structuring, organizing, and optimizing all existing processes in the enterprise. This leads to higher efficiency and improved financial results, expanding market opportunities by increasing efficiency.

For department heads, QMS helps organize and control employees’ work, providing necessary oversight without micromanagement.

For employees, QMS creates clear instructions and knowledge of their duties and responsibilities. This enables them to act in various situations without constant recourse to management.

Furthermore, QMS provides a competitive edge by enhancing product quality, reducing business risks, promoting business scalability, and partnerships, which are crucial for entering foreign markets. Implementing QMS helps maintain relevance and compliance with standards and requirements, easing interaction with external counterparts and competent authorities.

Therefore, QMS is relevant for all levels of enterprise management, contributing to improved efficiency, control, and product quality.

Viktoriia also pointed out that every enterprise producing rehabilitation devices already has a Quality Management System in place. Each enterprise currently operates with applications and forms as required by current legislation. Of course, various processes take place in production: manufacturing, interaction with patients, physicians, competent authorities, handling complaints, and so forth. Therefore, the system currently functions based on the company’s experience and personnel. But without a proper Quality Management System, all these processes occur chaotically. By implementing a Quality Management System, all processes in production are organized and aligned with requirements.

The Quality Management System must be documented according to the ISO 13485 standard. This includes policies, quality objectives, quality manuals, standard operating procedures, work instructions, job descriptions, record forms, and so on.

The lifecycle of the quality system consists of four stages: development, implementation, certification, and maintenance.

During the first stage, development, it is necessary to tailor the system to a specific enterprise considering production peculiarities, outsourcing, etc. To do this, the scope of the Quality Management System needs to be defined, specifically, the products manufactured by the producer. Attention should also be given to processes: what the manufacturer does in-house and what is outsourced.

At this stage, the manufacturer may decide to engage an outsourcing company to develop the QMS.

It is also necessary to appoint a quality management representative and conduct a diagnostic audit. This assists the manufacturer in the preparation and implementation of the QMS.

A diagnostic audit is used to identify major non-conformities or potential issues. It also helps provide a realistic assessment of the quality management system’s status. Thus, the results of the diagnostic audit indicate the scope of future work: what needs changing, refining, or adding.

During the diagnostic audit, it’s crucial to be completely honest. The Quality Management System is not designed to highlight problems or shortcomings; it is created to improve and enhance production processes.

When developing the Quality Management System, the manufacturer considers various legislative requirements and standards such as ISO 13485 and others. The primary principle of the system is a process-based approach that allows planning and controlling all interconnected types of enterprise activities to achieve planned goals.

The process-based approach involves addressing input data and transforming it into output that influences subsequent processes or becomes input for new processes. Addressing input requirements and meeting client and legislative requirements are the primary objectives. If the enterprise fails to meet the requirements, processes are reviewed to identify issues and non-conformities.

Post-market surveillance is also part of the production processes. If a product leads to an incident, the manufacturer must assess it as a non-conformity and take steps to prevent such incidents from recurring.

Standard Operating Procedures (SOPs) developed at the enterprise depend on the type of enterprise and the processes it executes. There must also be work instructions, which are developed depending on the processes performed. Work instructions provide clear directions on what personnel should do in specific situations, such as how incoming inspections are conducted, how products are stored, how technical maintenance, service, or disposal of products are performed, or how measurements for prosthetics are conducted.

According to the ISO 13485 standard, there might be several exceptions in enterprises producing custom-made devices. For instance, if the product is not sterile, the relevant points in the standard on sterility do not apply. There could be several such points not applicable in the ISO 13485 standard. The manufacturer must provide justification for each exception, explaining why these points are considered exceptions.

In her report, Viktoriia provided an example regarding supplier assessment. The manufacturer must have clear criteria to assess their raw material suppliers, component providers, etc. For instance, verification of whether the supplier has a certified Quality Management System (QMS), the ability of the supplier to meet volume requirements, their reputation, possession of relevant documents, and willingness to make specific improvements enhancing the quality of raw materials.

The presence of technical documentation at the supplier’s end is crucial because if it is absent, the final manufacturer would have to develop it independently, conduct appropriate tests, etc. Therefore, it is necessary to assess whether choosing such a supplier makes sense or if finding another one that provides technical documentation would be better. Additionally, attention must be paid to logistics feasibility, product cost, price-to-quality ratio, and payment terms.

ISO 13485 allows the manufacturer to outsource certain processes or even the entire production, but the manufacturer must have means for quality control, including written agreements.

For instance, according to strict and precise requirements, the manufacturer may only collaborate with a supplier holding an ISO 13485 standard certificate. The manufacturer continually monitors changes and updates the list of approved suppliers as a supplier might, for instance, fall behind current requirements, and the final manufacturer wants to produce superior and higher-quality goods, thus requiring better raw materials. The manufacturer can enhance their suppliers by conducting audits, checks, identifying non-conformities, etc.

Another SOP discussed was the SOP for managing feedback from customers. Viktoriia emphasized that this SOP is very business-oriented as it focuses on the customer, ensuring continuous improvement in interactions with customers, clients, and patients.

Thus, when the manufacturer implements QMS and develops SOPs, they progressively become a trusted and reliable manufacturer, one that customers want to purchase from and collaborate with.

The next stage in the lifecycle of QMS is its implementation. This stage is crucial as it is when the quality management system begins to function. Documents written on paper transition into actual usage in production processes. At this stage, the staff must undergo training and conduct initial internal audits, while the management analyzes how the system starts to operate within the enterprise.

The staff needs training on ISO 13485 for QMS, ISO 19011 for internal audits, ISO 14971 for risk analysis, and, of course, the requirements of the Technical Regulations for medical devices.

Internal audits involve the manufacturer’s responsibility and actions to consistently confirm that the QMS is operational, effective, and meets the requirements of the ISO 13485 standard. In essence, the manufacturer must constantly ensure that their quality management system is efficient, thus maintaining its support.

Sometimes, manufacturers make mistakes when implementing QMS, and the report highlighted the most common issues arising during the implementation of Quality Management Systems in enterprises.

Often, employees fail to understand the purpose of QMS. Hence, the management needs to explain that QMS leads to positive outcomes, high operational efficiency, and streamlined processes. This happens because employees do not know how to work with QMS. Therefore, it is essential to ensure proper training for employees, conducted regularly. If the manufacturer lacks an appropriate person to conduct internal training, they may seek an external institution to provide the necessary training.

It is quite common to have an insufficient number of quality personnel in production. In such cases, the manufacturer should find an employee dedicated to quality matters or train existing staff.

Sometimes, there might be a lack of financial resources, but it should be considered that certain QMS-related expenses are investments in the future and, as a result, lead to achieving very high results, as seen in many companies that have implemented QMS.

Also, the implementation of QMS can sometimes take a very long time, 2-3 years. This should not be the case, since QMS should be implemented swiftly.

The next stage is the certification of QMS. After conducting internal audits and observing how QMS operates, the manufacturer can proceed with certification. Auditors will visit the enterprise, conduct an audit, and check if the company truly complies with ISO 13485 requirements. If it does, the production will receive the QMS approval certificate according to ISO 13485. Presently, audits in Ukraine are conducted on-site, but if justified, remote audits might be possible.

Is it necessary to certify QMS? Specifically talking about custom-made products, QMS should be in place, but it does not necessarily need certification. Therefore, the decision to certify under the ISO 13485 standard is voluntary. However, for products with a high-risk classification such as Is, Im, IIa, IIb, III, a certified quality management system is mandatory. This means that the system must have a certificate confirming its compliance with the ISO 13485 standard.

A common question arises regarding whether Ukrainian certificates for compliance with ISO 13485 requirements are accepted in the European Union.

Ukrainian certificates DSTU EN ISO 13485:2018 are accepted in the EU since the National Agency of Ukraine for Accreditation (NAAU) holds an equivalent accreditation with more than 80 countries, including the European Union.

It is crucial that the conformity assessment body issuing the ISO 13485 certificate to the manufacturer is accredited by the NAAU according to the DSTU EN ISO/IEC 17021-1 standard and has DSTU EN ISO 13485:2018 standard in the accreditation scope. Only such a QMS certificate is valid. If the certificate lacks the appropriate NAAU accreditation symbol, the ISO 13485 cannot be used either in Ukraine to confirm compliance with requirements or in the European Union.

Support and continual improvement of the Quality Management System is an ongoing process. Enhancing the quality system directly impacts process optimization within the company, boosts production efficiency, and ensures customer satisfaction. The Deming Cycle, with its concept of Plan-Do-Check-Act, is applied for the constant improvement of the system and processes within the enterprise.

To conclude, Viktoriia emphasized the benefits of having QMS and consistently enhancing it. Specifically, by improving the QMS, manufacturers manage risks associated with the production of medical devices, ensuring greater safety, reliability, and control. Having QMS aids in fostering the development of new technologies by continuously refining processes. This may lead to the invention of new technologies or methodologies. When everything functions properly within the enterprise, manufacturers can easily enter new markets and swiftly adapt to new, even higher, requirements. The continual adaptation to new demands makes this process simpler and less financially and resource-intensive than attempting to implement these changes abruptly in the future.

Ukraine also plans to implement new requirements, including MDR and IVDR. Therefore, ongoing adaptation and compliance with the requirements now will help avoid significant expenses in the near future. Investing in a quality management system has numerous benefits for businesses as it ensures safety, enhances efficiency, controls costs and resources, and improves customer satisfaction levels. This is crucial for keeping the products competitive.

If you have any questions, please feel free to reach out to us. We would be happy to assist in finding the right solutions regarding the regulation of medical devices.

You can send your queries via email to: info@cratia.ua.

Additionally, you can call us at: +38 (068) 064-78-31, where you will receive immediate consultation regarding medical devices.

Best regards,
The Cratia team