MDSAP certification

Provides market access pathway in multiple geographies including USA and Canada

Inspiration Healthcare Group plc (AIM: IHC), the global medical technology company pioneering best-in-class, specialist neonatal intensive care medical devices, announces that its UK-based operating subsidiaries have achieved Medical Device Single Audit Program ("MDSAP") certification, confirming their Quality Management System processes comply with the requirements of the EU, USA, Japan, Australia and Canada. Airon Corp, a company based in Florida USA, that the Company acquired recently, is already certified for MDSAP for certain export markets.

The MDSAP certification is a global initiative allowing medical device manufacturers to undergo a single regulatory audit to demonstrate compliance with the quality and regulatory requirements of multiple international jurisdictions. Inspiration Healthcare's subsidiaries have been approved for MDSAP certification following a successful audit by BSI, an accredited Notified Body.

Streamlining the audit process for medical technology companies' quality management systems, MDSAP replaces regional audits with a single, consolidated audit across several major markets. MDSAP certification is optional in some jurisdictions but importantly, it is compulsory for access to the Canadian market. With MDSAP certification achieved, the Company can now initiate further product registrations in Canada, marking progress towards its strategy of expanding the presence of its product portfolio in North America.

Neil Campbell, CEO of Inspiration Healthcare, commented: "We are delighted that our UK subsidiaries have achieved MDSAP certification, which will simplify the audit process across existing markets and help accelerate market access to important new geographies, including the USA and Canada, which are key long term growth markets for Inspiration Healthcare. The MDSAP process is extremely thorough, as it combines the audit of several quality management system requirements into a single audit. Our team not only had to combine these requirements but also ensure that three operating companies within the Group all had their processes aligned. I would like to thank the team for their hard work in achieving this milestone and we look forward to increasing the growth of our business internationally."