Quality Assurance & Regulatory Affairs | Head of Training
Peter is Principal consultant Quality and Regulatory Affairs and Head of Training within the Qserve Group.
After an extensive career at KEMA Quality (nowadays known as DEKRA Certification) Peter joined the Qserve Group in 2007 to combine his quality system knowledge with the regulations in the medical device industry.
Peter uses a pragmatic and practical approach with a strong focus on strategic and operational compliance and excellence. He is well known for his trainings.
The key expertise areas of Peter
- Transition from EU MDD to EU MDR
- In-company and in-house trainings, courses and workshops on several subjects: EU MDD, EU MDR, QMS, Risk Management, Technical Documentation (STED), Internal (lead) auditor, Vigilance, Regulatory pathways and many more…
- Qualified trainer on all medical device related trainings
- Quality Management
- Risk Management
- History Files and Technical Files of a range of devices for low-risk (Class I) to medium risk devices (Class IIb) for submission to Regulatory Authorities in EU, US and Canada; the devices range from wound care products to medical electrical equipment for use in the Healthcare Sector
- Expert advice on the interpretation of the Medical Device Directives and other laws pertaining to in regard to items such as regulatory pathways, classification, including preparation of rationales
- Interim Quality Assurance & Regulatory Affairs manager at various companies with medium risk medical devices
- Project Planning & Management
- Qualified Lead auditor ISO 13485, CE certification, Annex V and Annex VI MDD 93\42\EEC for Notified Body
- Quality Management systems at various companies in the profit and not for profit sectors: industry, trade, IT-software support, (nuclear) energy industry and medical industry, government and civil services, public services
- Interim Quality Assurance manager
Peter is an expert on Quality Management System requirements. He obtained for more than 25 years of experience as consultant, lead auditor and trainer.
With his background as physicist Peter is mainly concerned with medical electrical devices.
Peter holds a MSc degree in Physics of the Leiden University.
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