Rachel Gibbs has over 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 EU and UK legislation to advise Clients regarding regulatory and clinical strategies, classification issues, undertaking Gaps Assessments, authoring MDR technical documentation and advising on Notified Body review questions.

Rachel has a strong scientific background with a degree in Biochemistry and a PhD investigating the role of the immune response within abdominal aortic aneurysms. She started her career at the Medicines and Healthcare Products Regulatory Agency (MHRA) working on medicinal product variation and renewal licensing. Rachel then spent 10 years in product development for the medical device and pharmaceutical industries. She joined 3M Healthcare, Drug Delivery Systems Division, working in late-phase product characterization and PIL studies, including stability testing, of metered dose inhalers and nasal sprays for US FDA and EMEA drug applications. With the opening of 3M’s Skin and Wound Care Laboratory, she transitioned into the medical device industry. She becam 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 moved to BSI in 2015 and spent 6 years as a Senior Scheme Manager/Technical Specialist (auditor). Her specialist area is wound care. As a Technical Specialist Rachel has conducted more than 250 Class IIa/IIb technical file audits and over 100 Class III design dossier reviews and changes against the Medical Device Directive (93/42/EEC) and Medical Device Regulation ((EU) 2017/475). Rachel is qualified under the MDR to conduct audits for wound care (MDN1204), but also holds codes for auditing non-active, non-implantable devices (MDN 1201, 1202, 1208). She is also a qualified Clinical Evaluation Specialist with ISO 13485 lead auditor training.

CORE COMPETENCIES

• 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
  • Strategizing the appropriate regulatory pathway for a device, including consideration of speed to market vs regulatory compliance risk
• Technical Documentation preparation per Annex II and III of the MDR
  • Area of expertise specifically design control but also including risk management files, stability and transit reports, manufacturing/packaging validation, GSPR checklists, clinical evaluation and biological assessment report
• Technical documentation gap assessment from the auditor’s perspective, including remediation planning and/or documentation re-writing
• Clinical Documentation Expertise: Conducted MDR reviews as a Clinical Evaluation Specialist at BSI and written Clinical Evaluation Assessment Reports (CEARs) for Notified Bodies
  • For clients, authoring of PMS documentation (PMS/PMCF plans and reports, PSURs) and SSCPs
• Expert knowledge of Medical Device Coordination Group (MDCG) guidance
• Support Client meetings with Notified Bodies and addressing Notified Body questions
• Specialist Field: Wound care and sutures

RECENT PROJECTS

• Authoring MDR technical documentation submission documentation for class III and IIb sound dressings
• Strategy for the regulatory pathway for an MDR up-classified herbal nasal spray
• UK and EU clinical strategy for feeding tube at early phase of development

PUBLICATIONS (née Middleton):

• NAMSA Webinar 2023: Guide to Writing SSCPs.
• RAPS 2022 US Convergence: Recent Developments in EU Regulations & Clinical Evaluation: SSCP and Readability.
• RAPS 2022 EURO Convergence: SSCP: A Practical Approach and Lessons Learnt So Far.
• TOPRA MSc Module 15: SSCP Requirements. Speaker (2022).
• TOPRA MSc Module 15: The Notified Body Perspective on Clinical Evaluation – The CEAR. Speaker (2022).
• Gibbs RK. Biomaterials for Healthcare Special Interests Group.  Nottingham, March 2014
• Gibbs RK. Medical Device Development: Navigating the Complex Pathway to Market.  Presented at: Design for Health and Wellbeing Conference. Nottingham, February 2014
• Middleton RK, Lloyd GM, Bown MJ, Cooper NJ, London NJ, Sayers RD. The Pro-inflammatory and Chemotactic Cytokine Microenvironment of the Abdominal Aortic Aneurysm Wall: A Protein Array Study. J. Vasc. Surg 2007: 45:574-580
• Middleton RK, Lloyd GM, Bown MJ, Jones LJ, Sayers RD. The Inflammatory Infiltrate is a Source of Up-regulated Interleukin-8 and Monocyte Chemoattractant Protein-1 within the Abdominal Aortic Aneurysm Wall. Eur J Vasc Endovasc Surg. 2009;37:46-55
• Middleton RK, Lloyd GM, Bown MJ, Jones LJ, Sayers RD. Abdominal Aortic Aneurysms Express Interleukin-8 and Monocyte Chemoattractant Protein-1. Presentation at: The Association of Surgeons of Great Britain and Ireland. Edinburgh, May 2006 (Podium presentation).
• Middleton RK, Lloyd GM, Bown MJ, Cooper NJ, Jones LJ, Sayers RD. The Inflammatory Infiltrate is a Source of Up-regulated Interleukin-8 and Monocyte Chemoattractant Protein-1 within the Abdominal Aortic Aneurysm Wall. Presented at: Society of Academic and Research Surgery. Edinburgh, January 2006 (Poster & Podium presentation).
• Middleton RK, Bown MJ, Lloyd GM, Cooper NJ, Sayers RD. Chemotactic Cytokines are Up-regulated in Abdominal Aortic Aneurysms. Presented at: Society of Academic and Research Surgery. Newcastle, 2005 (Podium presentation).