Regulatory affairs / Quality assurance Manager & Medical Device Consultant
Erwin is QA/RA manager for Peercode’s medical device software. Additional he is medical device consultant. Erwin is part of Peercode’s Regulatory and Quality Team.
Erwin gained international experience with medical device registration projects when working for different large and small pharmaceutical and med tech companies. Erwin has experience as a global project lead for technical documentation and submission strategies and participated in health authority and Notified Bodies consultations and audits. The projects ranged from self-registration Class I products to Class III and drug-device combination products. Erwin is trained on GCP, GMP, Quality and Risk Management (ISO 13485/9001 and 14971) and auditing.
Erwin has also gained wide experience as regulatory and quality consultant. Erwin has presented at conferences, provided training on medical devices regulatory topics, written several white papers and is a member of RAPS. Erwin is medical biologist by training and holds a PhD in Medical Sciences. Erwin is enthusiastic about helping Peercode and its clients to gain regulatory and quality success.