Medical Device Regulatory Practices (PDF)
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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.
- Autor: Val Theisz
- 2015, 590 Seiten, Englisch
- Verlag: Taylor & Francis
- ISBN-10: 9814669113
- ISBN-13: 9789814669115
- Erscheinungsdatum: 03.08.2015
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- Dateiformat: PDF
- Grösse: 14 MB
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