At Clamason Industries we take great care to safeguard customer confidentiality so therefore cannot detail the growing number of medical devices incorporating our precision components, which go well beyond the more traditional pressed scalpel blades, pins and implants.
We can however quote the capabilities and procedures we have in place to ensure that our engineering solutions meet the exacting standards demanded of medical device protocols.
All Clamason medical components are fully process validated using Design, Installation, Operational and Production Qualification protocols (DQ / IQ / OQ / PQ). In addition, the Clamason team is trained in the use of URS (User Requirement Specifications), CAPA (Corrective and Preventative Actions) and GMP (Good Manufacturing Practice).
Our £40,000 Simac Masic 3D realtime vision system measures and monitors in 3D 100% of thin and intricate healthcare components fed from a high-speed press in a continuous strip and requiring measurement of key features to 50-micron tolerances.
In the QA Department, our Nikon Nexiv 3020 non-contact, CNC video measuring system featuring a through-the-lens laser autofocus facility ensures the repeatability of small, complex and highly toleranced parts from large batch production. Such monitoring of key dimensions enables Clamason for example to anticipate when and where adjustments need to be made to the process.
The QA Department also operates a £60,000 Brown & Sharpe Mistral CNC co-ordinate measuring machine, with a Renishaw PH10M contact probe, for the checking of high-tolerance parts having complex 3D forms and the preparation of associated reports. |