FastForm Quality & Regulatory Affairs

Reflecting our commitment to excellence in all areas of our business, FastForm is proud to have achieved ISO13485 certification in 2006.

The FastForm quality system brings best practice to all aspects of the business allowing FastForm to develop safe and effective medical devices within a short lead time. The quality system, accredited by NSAI, conforms to ISO13485: 2003 and ensures that medical devices for orthopaedic and related applications are designed, developed and manufactured to be both safe and effective in use.

FastForm medical devices for sale in Europe are CE marked and conform to the requirements of the Medical Device Directive 93/42/EEC, while products for sale in the US comply with 21 CFR 820 regulatory standards.