EU MDR Annex II Technical Documentation Details: Too Much? Too Little? What is “Just Right”?

Ginger Swassing is an accomplished Regulatory Affairs Professional with over 35 years of experience in the healthcare industry. Her work experience spans in vitro diagnostic and medical device businesses. Ginger managed the global regulatory strategies and approvals to maximize commercial benefit for all classes of device and diagnostic products. Through her experience in the successful filing/approval of CE Mark devices and diagnostics, Ginger has worked successfully with many different Notified Bodies through contract negotiations, ISO audits and product approvals. She has managed global regulatory organizations and has led the development and remediation of procedures in quality compliance remediation efforts for large multinational manufacturing organizations.

As a consultant since 2015, Ginger has provided guidance to medical device companies in interpretation of the European Union medical device regulations. In this role she developed strategies, procedures and templates to enable the smooth transition from the medical device and in vitro diagnostic directives to the MDR and IVDR.

Prior to the start of her consulting career, Ginger was employed by Abbott Laboratories for 25 years. As Director of Regulatory Affairs for Abbott Vascular and Manager Regulatory Affairs in Abbott’s Diagnostic Division, she was responsible for the full product life cycle regulatory strategies for a broad portfolio of medical devices and IVDs. She established a Regulatory Operations team and managed regulatory subject matter and professional development training. She also held leadership positions in Technical Product Development, and Quality Systems at Abbott.

Ginger earned a Bachelor’s of Science in Chemistry from the University of Denver, Denver, CO. She has received numerous awards and recognition for her excellence in technical product development, regulatory approval and business efficiencies while employed at Abbott Laboratories. Ginger currently holds the following certifications: RAPS RAC (US and EU).

Jan is a Partner with Validant bringing over 25 years of experience and a broad background in Quality, Regulatory Compliance, Design, Manufacturing and Logistics. Prior to becoming a Partner at Validant, Jan was a Validant consultant and project team lead. Jan also worked in multiple roles of increasing responsibility at Beckman Coulter. Jan has a Bachelor of Science degree in Mechanical Engineering, a Master’s in Business Administration and a Professional Engineering License in the State of California. In addition, she has completed multiple post-graduate courses and Quality certifications.

Deborah Madsen, Consultant at Madsen QRC, LLC, holds a degree in Electrical Engineering and is a Registered Professional Engineer in the state of California. Madsen QRC provides quality system and regulatory compliance consulting to the medical device and in vitro diagnostic device industries. Deborah Madsen has over 30 years of experience in the design, manufacture, quality assurance and regulatory compliance of medical and in vitro diagnostic medical devices. Over a period of 21 years, Deborah held several roles at UL, including product safety engineer, lead auditor, technical instructor, and NB technical file assessor. Over a period of 8 years at Beckman Coulter, Deborah managed the in house product safety, EMC, reliability and product performance laboratory. More recently, Deborah has held roles as Director of Quality and Regulatory for medical device and IVD start-ups.

Dr Sharmila Gardner is currently a Regulatory Lead at BSI but, prior to this, was a Technical Team Manager and, Technical Specialist and Scheme Manager within the Active Devices Team. Dr Gardner has been managing certification, performing technical and clinical reviews and providing regulatory support for the last 12 years, gaining an in-depth knowledge of medical device regulatory requirements. She has over 22 years’ experience in the development, validation and CE marking of medical devices and, clinical and scientific instrumentation. She previously worked at Otodynamics Ltd and GlaxoSmithKline. Dr Gardner holds an MSc in Medical Electronics & Physics from the Medical College of St Bartholomew's Hospital and a PhD in Clinical Engineering from the University of Liverpool.