Clamason have been producing components for the Medical market since 1999 and were first awarded the BS13485 accreditation in 2008. The main focus of medical component production at Clamason has been for components that are assembled into medical devices like dry powder inhalers or Insulin drivers.
The process is comprehensively validated to Design, Installation, Operational and Production Qualification protocols (DQ / IQ / OQ / PQ), working within the requirements of the US Food & Drug Administration’s Code of Federal Regulations, (FDA) Title 21, ‘Part 820: Medical Devices – Quality System Regulation’.
Clamason is capable of fully process validating all its medical components by means of these protocols. In addition, the Clamason team is trained in the use of CAPA (Corrective and Preventative Actions) – essential for medical industry processes.
All of the above activities are done in house at Clamason, for components that have a medical validation requirement click here to discuss further.
Producing components for Medical market for 20 years
ISO: 13485 accredited
Components for dry powder inhalers or Insulin drivers
All components fully process validated
Staff trained in use of Corrective and Preventative Actions