Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)
| Autor: | Joy Frestedt |
|---|---|
| EAN: | 9780443220647 |
| eBook Format: | PDF/ePUB |
| Sprache: | Englisch |
| Produktart: | eBook |
| Veröffentlichungsdatum: | 27.09.2024 |
| Untertitel: | A Practical Guide for the European Union and Other Countries |
| Kategorie: | |
| Schlagworte: | Medical device evaluation; clinical evaluation; post-market surveillance; CER; risk management; clinical data identification; clinical data appraisal; clinical data analysis; device vigilance; safety; performance |
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Joy Frestedt Is the President and CEO for Frestedt Incorporated, a consulting group of over 70 experts providing services in broad CRQE areas of clinical trial development and execution, as well as US and international regulatory compliance, management of corporate quality systems, and biomedical engineering. She has managed clinical research, regulatory affairs, and quality systems for more than 40 years and has published more than 100 manuscripts, as well as book chapters. With a PhD in Pathobiology from the University of Minnesota Medical School, her experience includes designing, conducting and overseeing clinical trials as well as negotiating regulatory submissions and developing quality systems for companies like the University of Minnesota, Orphan Medical, Astra Zeneca Pharmaceuticals, Johnson and Johnson, Medtronic, and Mayo Clinical Trial Services.
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