Module 14 2022

22/03/2022

Non-Clinical Evidence

Under the IMDRF structure, this section incorporates both quality and non-clinical verification and validation

• NC studies: • Mechanical / physical / material characterisation / selection

• Electrical safety • Radiation safety • Software • Biocompatibility and toxicology • Usability and human factors

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

21

Risk Management

The MDR aligns with ISO 14971:2019 and ISO 13485:2016 Needs to be a summary that: • Explains the risks identified • How they are controlled to an acceptable level • Conclusion, including how remaining risks are acceptable when compared to the benefits. • Often this is best presented in a tabular format for ease of review

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

22

11