Verwandte Artikel zu Planning, Writing and Reviewing Medical Device Clinical...
Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs): A Practical Guide for the European Union and Other Countries - Softcover
Inhaltsangabe
A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices that is in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs.
Die Inhaltsangabe kann sich auf eine andere Ausgabe dieses Titels beziehen.
Über die Autorin bzw. den Autor
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.
Von der hinteren Coverseite
A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs.
„Über diesen Titel“ kann sich auf eine andere Ausgabe dieses Titels beziehen.
Suchergebnisse für Planning, Writing and Reviewing Medical Device Clinical...
Beispielbild für diese ISBN
Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs): A Practical Guide for the European Union and Other Countries
Anbieter: Ria Christie Collections, Uxbridge, Vereinigtes Königreich
Verkäuferbewertung 5 von 5 Sternen
Zustand: New. In English. Artikel-Nr. ria9780443220630_new
Neu kaufen
EUR 173,11
EUR 17,42 Versand
Versand von Vereinigtes Königreich nach USA
Versand von Vereinigtes Königreich nach USA
Anzahl: Mehr als 20 verfügbar
Foto des Verkäufers
Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs)
Anbieter: moluna, Greven, Deutschland
Verkäuferbewertung 5 von 5 Sternen
Zustand: New. Identifies and explains data analysis for clinical evaluation of medical devicesTeaches readers how to understand and evaluate medical device performance and safety in the context of new regulationsProvides analysis of new clinical. Artikel-Nr. 897996785
Neu kaufen
EUR 179,17
EUR 48,99 Versand
Versand von Deutschland nach USA
Versand von Deutschland nach USA
Anzahl: Mehr als 20 verfügbar
Foto des Verkäufers
Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) : A Practical Guide for the European Union and Other Countries
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Verkäuferbewertung 5 von 5 Sternen
Taschenbuch. Zustand: Neu. Neuware - A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices that is in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Artikel-Nr. 9780443220630
Neu kaufen
EUR 344,69
EUR 39,26 Versand
Versand von Deutschland nach USA
Versand von Deutschland nach USA
Anzahl: 2 verfügbar