PROSYSTEM, an NSF International company, specializes in consulting and services in biomedical engineering including regulatory affairs, clinical evaluations, usability, risk management, medical device registration, lifecycle management, software development and quality management.
Based in Hamburg, Germany, the PROSYSTEM team of technical experts serves clients worldwide and has a deep knowledge of the European medical device industry and its changing regulatory environment.
We can provide guidance on new supply chain traceability requirements, new standards for clinical evidence and more rigorous reporting and post-market surveillance requirements.
News and Events
Medical Device Leader Workshop Predicts Disruptive Change in Technology and Regulatory Landscape
October 18, 2019
New NSF Training Center in Hamburg Helps Medical Device Makers Comply With EU Regulations
December 3, 2018
NSF International Expands Medical Device Consulting Services in Europe With Purchase of PROSYSTEM AG
October 9, 2017
Plumbing Standard Revisions Tighten Lead Leaching Criteria in Drinking Water
September 22, 2020