Quality Management, Regulatory Affairs & Biocompatibility

The module is designed to give learners a clear understanding of the roles of Quality Management, Regulatory Affairs and Biocompatibility, particularly as applied to the medical device and healthcare sector It will provide learners with the skills and information to enable them to interpret and understand the regulations and their associated standards in relation to sterilisation and biocompatibility practises for medical devices in Europe and the US with reference to other markets and to apply this knowledge to real world scenarios. It will also provide learners with the information and skills to enable them to recognise the roles quality, regulatory affairs and biocompatibility play in the production of medical device products and to participate effectively as part of QA, RA and product development teams in the medical device Industry. Learners will have gained sufficient knowledge of the quality, regulatory and biocompatibility of medical device healthcare products to enable them to take up responsible positions in Product Development, QA, QC and RA within Industry.

1.  Evaluate legislation and regulations as well as the roles of the various regulatory agencies in governing the use of medical devices in the US, EU and other major markets.

2. Analyse the way in which the regulations feed into the Quality Management System with respect to sterilisation, microbiological control, biocompatibility & clean-rooms. 

3. Examine the ISO13485 and 21 CFR Part 820 Quality System requirements for medical devices with specific attention to patient safety, product quality and sterility. 

4. Evaluate how to achieve and maintain Quality System compliance via risk management, validation, calibration and change control methodologies.

5. Critically review the driving principles behind European and international biocompatibility quality and regulatory requirements and demonstrate improved material selection, process characterisation and toxicological risk assessment in medical device design and change management.