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:
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- 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):
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- a set of procedures and templates forming a ISO13485 compliant Quality Management System
- an elaborate internal/supplier audit trail template per process based on my knowledge and skills of having been a DEKRA and KIWA Dare! auditor
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
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
- 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 - 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
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
Mobile 06-12296826
Postal Address
Process Vision B.V.
Rogier v Leefdaelstraat 29
5081JK Hilvarenbeek
The Netherlands
Route