Pieter de Vries

I am a senior consultant in global medical device regulations and an expert in ISO 13485 certification.

I have worked almost 10 years for Notified Body DEKRA Certification (formerly KEMA Quality) as a Project Manager, managing accounts that need regulatory certifications. I performed technical documentation reviews, as well as quality system audits as an audit team leader. I conducted audits in many areas of the world, including Europe, Asia, Middle East, Africa and USA. I acted as global product expert for ISO 13485 and the Canadian CMDCAS program. As Certification Manager, I made decisions on granting, suspending or withdrawing certifications.

Before that, I have worked in several positions in the medical device industry (R&D, Manufacturing and QA/RA) and in a university hospital. My background is biomedical engineering and my expertise is with active medical devices (e.g. CT, MR, Cardiovascular X-Ray, Lasers, Ultrasound, Patient Monitoring, Rehabilitation and ENT), including software (stand-alone such as PACS, as well as embedded software) and IVD instruments.

Being a senior consultant, I can support you in many areas, such as:

– Set up of a quality management system (based on ISO 13485, ISO 9001, MDD, QSR or different);
– Conduct internal audits and/or supplier audits
– Act as QA/RA Manager in your organization
– Provide strategic advice on organizational aspects, e.g. multi-site organizations
– Provide training, coaching, hands-on support
– Interface with Authorities and Notified Bodies
– Participate in Management Reviews or Risk Management sessions
– Set up, review and maintain technical documentation