Medical devices is one of the most regulated industries, with high requirements for the quality management system (QMS) of the manufacturer. The presence of a QMS is mandatory for the manufacture of medical devices and medical devices for in-vitro diagnostics, whereas certification of the system is voluntary.
The field standard for quality management of medical devices is ISO 13485 “Medical devices. Quality management system. Regulatory requirements”. Ukraine has implemented a national standard (DSTU) which is identical to ISO 13485:2016 and included to the list of the harmonized standards, the use of which gives a presumption of conformity with the Essential requirements of the Technical Regulations.
Since 2016 the scope of the ISO 13485 standard has been expanded: it can be used not only by the manufacturer, but also by the importer, distributor, service center and organization performing related services. With the transition of the European Union to the new European directives for medical devices MDR and IVDR, the certification of the distributor for compliance with ISO 13845 becomes more and more important.
Since 2007 we have been professionally performing the development, implementation, training and independent audit of quality management systems for medical devices in accordance with ISO 9001 and ISO 13485 standards. By starting cooperation with us, you will receive a high-quality and professional result. We are professional, transparent, compliant and highly effective regulatory consultants.
We are not a certification body, we do not have an accreditation for certification of the quality management systems.
We offer following services related to development, implementation and audit of the QMS:
- Independent third-party audit of the manufacturer, importer, distributor, service center or Authorized representative for conformity with the ISO 9001, ISO 13485 or your guidelines;
- Gap analysis and preparation of the roadmap;
- Writing (development) of the QMS documentation (Quality manual, SOP’s, journals etc.) according to the chosen standards;
- Training of the personnel;
- Support and assistance during internal audits;
- Filling the Application, assistance during the certification.
We have the deep knowledge, experience and skills to pre-audit, develop and implement quality management systems in accordance with ISO 9001 and ISO 13485. We proactively and professionally organize the process in a short time.