Medical Device Regulatory Practices

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv

Val Theisz is a regulatory professional with over 15 years' experience in medical device regulations, of which she spent 8 in leadership roles in regulatory affairs, regulatory operations, and quality assurance. She holds a masters degree in electrical engineering from the Polytechnic University of Timisoara, Romania, and a Regulatory Affairs Certification (RAC) for European and US regulations from the Regulatory Affairs Professionals Society (RAPS). Val has been a RAPS fellow since 2010. Working on both sides of the regulatory divide-as a reviewer and quality systems auditor (7 years) and in roles with responsibility for obtaining regulatory approvals and maintaining regulatory compliance (10 years)-enabled Val to gain an in-depth understanding of the typical challenges facing medical device companies. One of her achievements was obtaining the CE marking approval for a life-sustaining active implantable medical device within six months from the date of submission. During a five-year stint as regulatory operations manager with one of the largest pharmaceutical companies, Val implemented electronic data management systems for a large product portfolio and learned about process improvement techniques.

Overview of risk classification systems and regulatory controls for medical devices and IVDs in established markets and GHTF harmonization: definitions and basic terminology related to medical devices. Core concepts of safety and effectiveness, use of standards, risk management, and clinical evaluation for medical devices. Design History File (DHF) and technical documentation content and structure that satisfies requirements in all key markets: Summary Technical Documentation (STED) and Regulated Product Submission (RPS). Premarket design controls and an example of market access strategy template including regulatory strategy, clinical strategy, and reimbursement strategy. Regulatory submissions and approvals in key markets. Post-market regulatory controls including change management, post-market surveillance, performance of quality management systems, and regulatory systems and processes.