Paul van Geffen, PhD

QA/RA Expert

Senior Consultant 

I have been working as conĀ­sultant in Medical Device Regulations for Qserve since 2010. I have provided QA/RA support for the medical device industry covering a wide range of medical devices:

  • Implants (hemostats; bone scaffold; brain stimulation; vertebral discs replacement)
  • Prosthetics and orthotics
  • Ophthalmic devices (contact lenses; eye ointments)
  • Surgical devices (episiotomy; robotic eye surgery and instruĀ­ments)
  • Endodontic materials (tooth filling)
  • Image guided surgery devices (interventional x-ray, ultrasound, CT and MRI)
  • Respiratory therapy devices (breathing/ventilation circuits)
  • Liquid devices (eye drops; dialysate)
  • Topical devices (wound dressings; anti-bacterials; anti-adhesives)
  • Software devices (CTG monitoring; information management; image guided surgery

The key expertise areas of Paul 

  • Medical Device Directive (93/42/EEC) and Medical Device Regulation (2017/745)
  • QMS development (ISO 13485, FDA QSR)
  • TF set-up/ review (CE mark and, to lesser extent, 510k)
  • Design controls and risk management (ISO 14971)
  • Biological evaluations (ISO 10993 series)
  • Clinical evaluations (MEDDEV 2.7/1)
  • European collaborative research projects (FP7)
  • Program-/ project management

Besides that, I am a certified trainer, (lead) auditor, and bio-compatibility expert

Paul about working at Qserve

“It’s great to work in a team with so much QA/RA knowledge and expertise and with such a dedicated focus on patient safety. Together we can really make a difference for our customers by reducing their regulatory burden, by translating the regulations into something understandable, and by increasing their awareness and acceptance of regulatory compliance”.

Before Qserve

Paul has degrees in Human Technology (BSc, 2001), Human Movement Science (MSc, 2004) and Biomedical Engineering (PhD, 2009). His dissertation was about the design, development and clinical investigation of a novel seating system enhancing functional movement and preventing physical discomfort in impaired static wheelchair sitting.

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