Rachel Gibbs has 15 years’ experience in the medical device and pharmaceutical industries, and also as a Senior Auditor for a leading European Notified Body. Rachel joined NAMSA in 2021 and has used her knowledge of MDR auditing to advise Clients regarding regulatory and clinical strategies, undertaking Gaps Assessments and writing MDR submission documents.
Rachel started her career at the Medicines and Healthcare Products Regulatory Agency (MHRA) working on drug variation and renewal licensing before moving back into academia to conduct a PhD in Immunology. Thereafter, Rachel moved into the pharmaceutical industry, joining 3M Healthcare, working on the development of metered dose inhalers and nasal sprays for U.S. Food and Drug Administration (FDA) and EMEA drug applications. With the opening of 3M’s Skin and Wound Care Laboratory, she transitioned into the medical device industry and was actively involved in new product development for a range of wound care devices, inclusive of design control, risk management, manufacturing upscaling and process validation. Rachel then moved to BSI in 2015 as a Senior Auditor and Clinical Evaluation Specialist involved in product conformity assessment to the Medical Device Directive (93/42/EEC), and subsequently audited against the Medical Device Regulation ([EU] 2017/475).
- New Product Development (NPD): Taking a medical device from concept phase through commercialization launch, including product development strategies for design development, scale up, design and manufacturing validation and stability studies
- Regulatory Strategies: Device classification, selection of the appropriate conformity assessment route and Notified Body
- Design Dossier and Technical File Preparation: Area of expertise, specifically design control, but also risk management files, stability and transit reports, manufacturing/packaging validation, General Safety and Performance Requirements (GSPR) checklists, clinical evaluation and biological assessment reports
- Gap analysis of technical and clinical documentation to the requirements of the Medical Device Directive and MDR, with the knowledge of Notified Body’s interpretation of the requirements
- Clinical Documentation Expertise: Conducted MDR reviews as a Clinical Evaluation Specialist at BSI and written Clinical Evaluation Assessment Reports (CEARs) for Notified Bodies
- Expert knowledge of Medical Device Coordination Group (MDCG) guidance
- Support Client meetings with Notified Bodies and how to address non-conformities
- Specialist Field: wound care and sutures
- Conducted a Quality Management System (QMS) Gap Analysis of Post-Market Surveillance (PMS) procedures against MDR requirements; developed PMCF strategy and plan to address highlighted deficiencies
- Generated multiple SSCPs for Class III implantable absorbable devices, including healthcare professional and patient sections and in line with the requirements of MDCG 2019-9
- Product development and regulatory strategy for an EU/U.S. submission bone filler product