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
OEHHA Issues Proposed NSRLs for Three Disinfection By-Products
August 11, 2020
On May 22, the California Office of Environmental Health Hazard Assessment (OEHHA), which assesses health risks of environmental contaminants in products sold in California, issued three notices of proposed rulemaking (NPRs) establishing proposed no significant risk levels (NSRLs) for three water disinfection by-products : trichloroacetic acid, dibromoacetic acid and dichloroacetic acid; also known as haloacetic acids. These NPRs were open for comment until July 7. OEHHA is now reviewing the comments and will then issue a final rule.