Midlands-based gas control specialist is one of few UK medical technology companies to receive prestigious regulatory milestone
BPR Medical, a UK-based leading independent manufacturer of medical gas products, has received Medical Device Single Audit Program (MDSAP) certification for its medical gas solutions. The certification, which has been awarded to just a handful of companies in the UK medical technology industry to date, is validation of the company’s dedication to providing high quality medical gas therapy products across hospital, home and hospice care.
The Medical Device Single Audit Program is an auditing standard for Quality Management Systems (QMS) that allows medical device manufacturers to undergo a single audit for compliance with ISO 13485 and the relevant requirements of USA, Canada, Brazil, Australia, and Japan.
By successfully completing the MDSAP audit, BPR Medical has demonstrated that its quality management system meets the strict regulatory requirements for the design, manufacture and service of medical gas therapy devices for respiratory therapy and pain management.
BPR Medical already provides gas therapy products to the NHS and UK and global healthcare providers. This certification will now enable the company to continue further expansion across the five markets covered by the accreditation.
The certificate award comes after the medical gas control specialist received a minimal number of Corrective Action Requests (CARs) during the audit process, below average for MDSAP.
Richard Radford, Managing Director at BPR Medical, said: “We have always strived to create the highest quality products, with every device we produce undergoing stringent tests at every stage of the production process. We are honoured to receive this recognition of our commitment to quality and regulatory requirements, and this now means we can continue making respiratory therapy safer for patients across the globe.”
BPR Medical is also CE marked under the Medical Device Regulations and received the prestigious Queen’s Award for Innovation in 2012 for the development of its revolutionary Firesafe™ range.
For further information please contact: Colin Hallmark, BPR Medical, Tel: +44 207 736 1888
Written by Medilink Member BPR Medical