Val Theisz

Medical Device Regulatory Practices (eBook, PDF)

An International Perspective

• Format: PDF

Produktbeschreibung

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

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 590
• Erscheinungstermin: 3. August 2015
• Englisch
• ISBN-13: 9789814669115
• Artikelnr.: 43976916

Autorenporträt

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.

Inhaltsangabe

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.