Pennine Healthcare Video


Quality Assurance

We have invested significantly in a purpose-built manufacturing facility at our headquarters in Derby. 

The plant covers almost 100,000 sq ft, incorporating an area for storage and loading, capable of handling over 2,500 pallets.  The site houses some of the most sophisticated technology in the industry, including two state-of-the-art clean rooms, operating to BS EN ISO 14644-1 standards.

  • In 1995 the company was accredited to EN 46001 standard.
  • Our quality system is accredited to ISO 13485:2012.
  • Clean room classification BS EN ISO 14644-1 ISO Class 8.
  • United States Food and Drug Administration (FDA) approval.
  • One of the first companies in Europe to be given the right to CE Mark our products.
  • Our sterilisation processes are re-validated annually to deliver a Sterility Assurance Level of 10-6
  • Our sterile products are presented in packaging that cannot be re-used, and which has the necessary seal strengths to maintain seal integrity during sterilisation, transport and storage.


Pleaes click here to view our Quality Policy.

Keeping all development in-house enables us
to set stringent quality standards required to
meet our 'right first time' approach