Lean but compliant
medical Quality & Regulatory services

Profile

Process Vision BV is established in 2000 and consists of Willem vd Biggelaar (see Curriculum Vitae and Qualifications)Customers are start-ups, medium and large medical device (related) companies.

Having been an ISO13485/CE auditor for DEKRA & KIWA Dare!!, Willem can easily form a bridge between customer and Notified Body.

Willem offers lean QA/RA consultancy services for the complete lifecycle of a medical device:

    • setting up/maintaining a ISO13485 compliant Quality Management System
    • setting up/maintaining the CE Technical Documentation
    • guiding the external audits from Notified Body
    • fulfilling the role of Quality / Regulatory Manager including performing internal audits

You can also buy a lot of process documentation so you have a swift start (contact Willem for a quotation):

Apart from above Willem offers training courses in the area of medical QA/RA. He is also active on conferences and education and is part of a consultancy network for knowledge and resource sharing.

The QA (Quality Assurance) part 

  • Role of QA manager
  • Setup MDR, ISO13485 & 21CFR820 compliant quality system 
  • Ensure keeping ISO13485 certificate
  • Execute internal & supplier audits
  • Guide development and production sites on QA matters
  • Guide external audits executed by notified bodies and FDA

The RA (Regulatory Affairs) part

  • Role of RA manager
  • Setup technical files to access markets (e.g. Europe, US)
  • Get and keep markets access  
  • Guide development and production sites on RA matters
  • Communicate with notified bodies and FDA

BUY YOUR QMS

This basic, lean, but complete Quality Management System (QMS) is compliant with the relevant regulations and process standard for manufacturers of medical devices. It requires minimal adaptation to fit it to your organisation!

The QMS consists of a quality manual, processes, procedures, guidelines, workinstructions and templates. See also the Table of Content. and check out a procedure and template example.

Willem has created a lot of Quality Systems for his customers.  After all these years, he now has a lean QMS that has been improved (and keeps improving) as a result of:

  • internal use by customers
  • audits by Notified Bodies and FDA inspections

This QMS is compliant with the following regulations and process standards:

  • ISO 13485 Quality management systems
  • MDR Regulation (EU) 2017/745
  • IVDR Regulation (EU) 2017/746
  • GDPR Regulation (EU) 2016/679
  • FDA 21 CFR 820 Quality System Regulation
  • ISO 14971 Application of risk management
  • IEC 62366-1 Application of usability engineering
  • IEC 62304 Medical Device Software
  • IEC 82304-1 Health Software
  • ISO 14155 Clinical investigation

So if you want a quick start with your QMS, contact Willem

What do you get? QMS Table of Content

Example of a procedure (CAPA)

Example of a template (CAPA)

Courses

Process Vision offers a large scale of courses / workshops on medical devices. Each course / workshop can be adapted to the customer wishes.

  • Medical Device Regulatory introduction
  • How to bring your device to the EU market (CE)
  • How to bring your device to the US market (FDA)
  • How to design a lean but compliant Quality Management System
  • ISO13485 Quality Management System for medical devices
  • ISO13485 Auditor
  • ISO14971 Risk Management for medical devices
  • IEC62366 Usability Engineering for medical devices
  • IEC62304 Software development for medical devices
  • IEC60601 Basic Safety & Essential Performance for medical electrical equipment
  • Medical Device Regulation (MDR)
  • FDA 21CFR part 820 Quality System Regulations
  • FDA 21CFR part 11 Electronic records and Electronic Signatures

Network

QA/RA ROLES

Process Vision regularly enters into partnerships with other medical regulatory consultants. This has major advantages: together you can work more hours for the customer, you can keep each other sharp and together you know more than alone.

Frank Aniba  – Aniba Consulting BV

Together with Frank,  Willem has guided several customers. E.g. at Preceyes Frank is RA and Willem the QA Manager. They are both QA/RA consultants for a number of customers. Frank also helps Willem’s other customers (and vice versa) on an ad hoc basis.


Paul Theunissen – GreyRA

Together with Paul,  Willem has guided Ventinova Medical , Paul being RA manager and Willem as QA manager. They are both QA/RA consultants for a number of customers. Paul also helps Willem’s other customers (and vice versa) on an ad hoc basis.

OTHER SPECIALISTS

The consultants below are togheter with Willem in a netwerk to discuss generic matters regarding entrepreneurship.

Emile Houben – Houben

Emile is Project Management Officer (PMO-er) en/of Project Manager (PM) sinds 1999 bij oa Philips en ASML. Emile heeft een Project Management applicatie in excel gemaakt op basis van de Prince-2 methode. Dit maakt het voor PM makkelijker om projecten te analyseren en te leiden in een gecontroleerde manier. Emile traint en coacht PM en ondersteunt afdelingen met het opzetten van project office / bedrijfsbureau. Een PMO kan een organisatie helpen grip te krijgen op hun projectportfolio waardoor zij hun doelstellingen beter, sneller en tegen lagere kosten bereiken. Mijn streven is om mijn klanten het plezier van een goed ingericht Project Office te laten ervaren.


 

Hans Jonker – Argo Consultancy BV

Hans heeft ruim 25 jaar ervaring in (software) productontwikkeling, waarvan de laatste 11 jaar in process verbeteringen (CMMI-assessor, SCRUM-Master, Prince2-Foundation) in grote en kleine bedrijven. Hij heeft ruime ervaring als QA Officer (ook FDA) en is sinds 2010 officieel ISO 9001/13485 lead auditor. Hij staat bekend om zijn positieve houding en enorme drive om een verandertraject in te gaan en tot een goed einde te brengen.


John van Spaandonk – Van Spaandonk & Koks

John heeft meer dan tien jaar internationale ervaring met het (bege)leiden van projecten. Hij combineert gedegen kennis van zaken met een doelgerichte en mensgedreven aanpak. Hij is inzetbaar als projectleider, trainer (algemeen projectmanagement, Prince2, Scrum) projectadviseur of coach.


Matt Verhaegh – COMM-IT

Matt heeft 25 jaar ervaring en heeft diverse rollen gehad in (software) ontwikkelprojecten bij grote multinationals en industriële middenbedrijven. Hij is inzetbaar als program/project manager, process (improvement) consultant, quality assurance officer en trainer/coach.


Marcel van der Laan – Saforama

Marcel zorgt er als Requirements Engineering consultant voor dat uw productontwikkelproces een solide basis vormt om uw product op te bouwen. Door de aanpak die hij hanteert, zorgen aanpassingen in organisatie, processen en ondersteunende technologie voor een blijvende verbetering. Onder zijn klanten bevinden zich zowel lokale bedrijven als multinationals. Hij heeft ervaring in verschillende markten en disciplines.


Sonja de Bruin – Themis Consultancy BV

Sonja is consultant op het gebied van kwaliteitsmanagement en eigenaar van Themis Consultancy. Zij verleent diensten op het gebied van kwaliteit in de breedste zin van het woord, aan middelgrote en grote IT bedrijven. Na haar afstuderen in 1993 aan de HTS richting Elektrotechniek, is zij in verschillende rollen binnen multi-disciplinaire IT projecten werkzaam geweest.

Articles

Process Vision has given lectures on conferences and for customers. Below some of these articles

Customers

 

Period Customer Role
2023 – now Log10 (Summox) QA / RA consultant / internal auditor
2023 – now Layco Medical QA / RA consultant / internal auditor
2023 – 2024 Flowview Diagnostics QA / RA consultant / internal auditor
2022 – now Smartmed QA/ RA consultant
2022 – 2023 Motek Medical QA/ RA consultant
2022 – now Praxa Sense QA consultant / internal auditor
2021 – now PMT Partners medische techniek QA consultant / internal auditor
2021 – now CD Leycom QA manager
2020 – now Mikrocentrum Trainer for medical devices
2021 – 2023 Salvia Bioelectronics Internal auditor
2020 – 2022 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 QA consultant 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 QA consultant
2012 – 2017 MediSpirit QA / RA consultant
2015 – 2016 Philips Health IGT Systems Internal Lead auditor, train auditors, improve audit process
2013 – 2014 Philips Consumer Lifestyle QA officer
2013 Philips Healthcare Incubator Handheld QA Manager
2011 – 2013 Philips Healthcare Incubator AdapTx QA Manager
2011–  2013 UTC Imaging RA consultant
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

 

Contact

Contact

 willem@processvision.nl

Mobile 06-12296826

Postal Address

Process Vision B.V.
Rogier v Leefdaelstraat 29
5081JK Hilvarenbeek
The Netherlands

Route

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