Process Vision | Lean Medical Device Quality & Regulatory Services

Period	Customer	Role
2020 - now	Mikrocentrum	Trainer for medical devices
2020 - now	EMRobotics	RA manager
2019 – now	TOPIC	QA manager
2019 – 2021	Dare!! medical certifications	CE & ISO 13485 lead auditor
2017 – now	Preceyes	QA manager, setup/review CE files
2011 – 2021	DEKRA certification	ISO 9001/13485/CMDCAS lead auditor
2012 – 2019	Sioux CCM	Assist QA manager, consult on medical projects
2014 – 2018	Ventinova Medical B.V.	QA manager, review CE files
2018	Vitestro Medical Robots	QA manager
2017 – 2018	Philips Health IGT Systems	Software Tool Validation manager
2016 – 2017	Frencken Mechatronics	Setup FDA 21CFR part 11 QMS, resolve FDA scope audit issues
2012 – 2017	MediSpirit	Setup ISO 13485 QMS, CE file, Setup CFDA file
2015 - 2016	Philips Health IGT Systems	Internal Lead auditor, train auditors, improve audit process
2013 - 2014	Philips Consumer Lifestyle	Setup 2 CE files, made QMS CMDR compliant, QA officer
2013	Philips Healthcare Incubator Handheld	Maintenance ISO 13485 QMS for IVD product
2011 – 2013	Philips Healthcare Incubator AdapTx	Setup FDA / ISO 13485 certified QMS
2011– 2013	UTC Imaging	Setup CE file
2010 – 2011	Sioux CCM	Setup and maintain ISO 9001/13485 certified QMS
2010 – 2013	Frencken Mechatronics	Setup ISO 13485 QMS and FDA compliant production line
2009	Philips Digital Pathology	Setup FDA / ISO 13485 certified QMS for IVD product
2008	Sintecs	Setup QMS
2008	Philips Healthcare PII	Medical QA officer
2007	D.O.R.C.	Get FDA clearance on software device
2007	EventIS	QA & CM manager
2006	Centric Tsolve	Setup CMM-I compliant QMS
2003 – 2005	Philips Medical Cardio Vascular	Medical System QA officer
2002 – 2003	Philips Medical Components	Medical Software QA officer
2001	Philips Medical, Components	Group lead SQA team /SPI coordinator
2000	Philips ASA lab	System QA officer
1996 – 1999	ASML	Software QA officer
1995	Dräger (ATOS Origin)	System Test Engineer / Embedded Software Engineer
1993 – 1995	Philips Medical, CV & MR (ATOS Origin)	Embedded Software Engineer
1993	Philips Nederland (ATOS Origin)	Embedded Software Engineer
1990 - 1991	Van Aaken	Embedded Software Engineer
1989 – 1990	Organon Technica (ATOS Origin)	Embedded Software Engineer
1988	Océ vd Grinten (ATOS Origin)	Embedded Software Engineer
1987 – 1988	Comdes	Embedded Software Engineer
1987	Volmac toptraining	Trainee

NEWS

Process Vision nominated as Best Knowledge Supplier 2019

Process Vision is door Preceyes genomineerd als Best Knowledge Supplier 2019 (Link Magazine)

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

Check this out

Scathing Indictmetn of FDA's regulation

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.