Gap Analysis & Due Diligence
With 24 years experience of medical device design and manufacture, Richard has a large base of experience, enabling him to identify gaps in current company processes. He has hands-on experience of the following aspects of medical device manufacture:
- Supplier Management
- Regulatory Affairs
- ISO 13485 (& associated harmonised standards)
- Medical Device Directive (93/42/EEC)
- In Vitro Medical Device Directive (98/79/EC)
- CE Marking and Technical Files and
- Internal, External and Notified Body Audits
We can therefore perform Gap Analysis for the companies themselves or Due Diligence on behalf of financial organisations on the following topics:
- ISO 13485:2016 - Existing QMS, and its conformance to the requirements of ISO 13485:2016
- Medical Devices - Existing medical Device CE Technical Files and their conformance to the MDD (93/42/EEC) and the MDR ((EU) 17/745).
- In Vitro Medical Devices - Existing IVD CE Technical Files and their conformance to the IVDD (98/79/EC) and the IVDR ((EU) 17/746).
Contact us today to see how we might help you!.