Medical devices have always played an important role in safeguarding human health. AP Engineering, with the many years of experience of its staff, is able to support medical device manufacturers not only on a European but also on an international level.
Thanks to our many years of experience in the field, we are able to handle the entire certification process, especially for active medical devices. The entry into force of the new medical regulation MDR 2017/745 has changed the certification scenario by requiring specialised skills that are not always present in companies. The MDR Regulation itself establishes and defines the figure of the Certification Manager and his/her powers and duties.
AP Engineering, with its extensive participation in regulatory technical seminars in the medical field, is able to provide a complete service encompassing the best definition of the strategy and certification pathway to the performance of testing, analysis and document drafting. We think about certification and our client, exclusively about development, sales and general business aspects.
Through our technical staff we are able to respond quickly to every need and request. Our time-tested approach is based on an in-depth knowledge of technical regulations and certification processes and specific steps involving:
- A preliminary analysis, with specialised technical inspections, aimed at identifying the technical reference standards and defining the entire certification process according to the target market.
- Preparation of the certification plan and testing.
- Preparation of certification documents including risk analysis, usability analysis, biocompatibility analysis, clinical validation and whatever is necessary to obtain certification.
- Detailed analysis of the applicable standards.
- Emission of a list of possible non-conformities with support and indication of possible actions to be taken thought out and evaluated according to actual use. We believe that protection and protective measures must be thought out and evaluated according to actual use, otherwise they will quickly be eliminated or bypassed due to the inability to use the machine.
- Managing relations with laboratories and certification bodies if necessary.