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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
  • IQC
  • Storage
  • Manufacturing
  • QC
  • QA
  • 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:

Quality Assurance

  • ISO 13485:2016 - Existing QMS, and its conformance to the requirements of ISO 13485:2016

CE Marking

  • 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!.