Medical Device Product development Processes (ID1013)

Barney Gerrard
MS.c.Durham University, UK

Competences:

• Medical Device product development processes:
  R&D process design conforming to ISO13485, ISO14971, FDA 820.30 QSR etc.
  Remediation of product documentation.
• Systems Engineering, requirements and traceability:
  Authoring, management and traceability.