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New Documentary Film Is Scathing Indictment Of FDA's Regulation Of Medical Devices

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4 Keys To Choosing The Right Regulatory Consultant

4 Keys To Choosing The Right Regulatory Consultant

By Bob Marshall, , Chief Editor, Med Device Online

I spent the first two decades of my medical device career with startups and larger OEMs, working with or hiring consultants, as needed, for support. I then became a consultant for seven years, and I saw outsourced support from the other side. Now, 18 months into my tenure as chief editor of Med Device Online, I want to share some perspective on outsourced support. These important relationships can make or break your business.

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Process Vision heeft diverse presentaties op conferenties en voor klanten gegeven. Hieronder een kleine greep:

 Help! Are we IEC62304 compliant?  Microcentrum Quality & Regulatory conferentie 2017, Eindhoven

 Help! Our Quality Management System is not used  QA & Test conferentie 2014, Bilbao, Spain

 Document and Record Control for Medical Devices 2014

 FDA requirements for suppliers 2013

 ISO 13485 in relation to ISO 9001 KZOB, 2011, Eindhoven

 Basics of Quality Control yearly OOTI course until 2010, TUE-Eindhoven

 Basics of Quality Assurance yearly OOTI course until 2010, TUE-Eindhoven

 Managing Requirements in real life QA & Test conference 2006, Bilbao, Spain

 Requirements ervaringen in de embedded wereld SERC, 1998, Utrecht


U kunt in onderstaand formulier vrijblijvend uw vraag op het gebied van kwaliteitsmanagement stellen. Wij zullen uw vraag zo spoedig mogelijk beantwoorden.