Prior to joining NAMSA in 2021, Michelle worked at the UK Competent Authority, The Medicines and Healthcare products Regulatory Agency (MRHA), for 14 years as head of biological safety. Her overall responsibility focused on the conduct and outcome of biological safety assessments undertaken by the MHRA, including review of clinical investigation applications, assessment of derogation and exceptional use requests, as well as management of major adverse events related to biological safety which carried significant public health implications.
Michelle is currently the chair of the National Committee for the Biological Evaluation of Medical Devices (CH/194). This committee is working at an international level to represent the UK in the development of key horizontal standards, including ISO 10993 series and ISO 14155. This work is striving for a standardized approach to biological and clinical evaluation of medical materials and medical devices. She is also a European-registered Toxicologist.
- Preparing evaluation plans and biological/toxicological risk assessments for medical devices in compliance with the ISO 10993 series of standards for submissions to Notified Bodies and Competent Authorities
- Reviewing biological evaluation reports as an employee of the regulator assessing clinical trial application submissions to the MHRA
- Evaluating and summarizing biocompatibility and general toxicology data to ensure compliance with the relevant regulatory requirements and standards
- Performing toxicological risk assessments of extractable and leachable chemicals from medical devices
- Subject matter expert on risk assessment of metal wear debris generated from orthopedic and dental devices
- Developing and implementing product safety assurance strategies under ISO1099
- Advising clients on technical issues related to biocompatibility and material characterization
- Performing biocompatibility gap analyses and writing clear concise reports
- Performing and summarizing literature searches
- Evaluating and determining biological relevance of unexpected results
- Advising clients on biological safety issues that arise following post market experience of their medical device
- Subject matter expert for demonstrating biological equivalence under the EU Medical Device Regulation (MDR)
- Successful Notified Body application for a heart monitor for a client that, prior to coming to NAMSA, was unsuccessful due to insufficient material characterization
- Biological evaluation reviews for a wide range of medical devices spanning the full cohort of device categorization, including cannula, surgical suture and a cell collection device