PROSYSTEM, an NSF 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.