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Process Vision nominated as Best Knowledge Supplier 2019

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

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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.

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Quality Assurance & Regulatory Affairs consultant

Period

Customer

Task

2019 – now

TOPIC

QA manager

2019 – now

Dare!! medical certifications

CE & ISO 13485 lead auditor

2017 – now

Preceyes

QA manager, setup/review CE files

2011 – now

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

Embedded Software / Test Engineer

Period

Customer

Task

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

 

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