Medical Device Regulatory Practices PDF ePub eBook

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Medical Device Regulatory Practices free pdf 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 effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets- important terminology needed to understand the regulators' language- and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

About Val Theisz

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.

Details Book

Author : Val Theisz
Publisher : Pan Stanford Publishing Pte Ltd
Data Published : 21 August 2015
ISBN : 9814669113
EAN : 9789814669115
Format Book : PDF, Epub, DOCx, TXT
Number of Pages : pages
Age + : 15 years
Language : English
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