MDSAP certification

Inspiration Healthcare Group PLC

18 January 2024

 

Inspiration Healthcare Group plc

("Inspiration Healthcare", the "Company" or the "Group")

Inspiration Healthcare subsidiaries achieve 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."

For further information, please contact:

Inspiration Healthcare Group plc		Tel: [phone]
Neil Campbell, Chief Executive Officer Alan Olby, Chief Financial Officer
Walbrook PR Ltd (Media and IR)	Tel: [phone] or [e-mail]
Anna Dunphy		Mob: [phone]
Stephanie Cuthbert		Mob: [phone]
Louis Ashe-Jepson		Mob: [phone]

About Inspiration Healthcare

Inspiration Healthcare (AIM: IHC) designs, manufactures and markets pioneering medical technology. Based in the UK, the Company specialises in neonatal intensive care medical devices, which are addressing a critical need to help to save the lives and improve the outcomes of patients, starting with the very first breaths of life.

The Company has a broad portfolio of its own products and complementary distributed products, for use in neonatal intensive care designed to support even the most premature babies throughout their hospital stay. Its own branded products range from highly sophisticated capital equipment such as ventilators for life support through to single-use disposables.

The Company sells its products directly to hospitals and healthcare providers in the UK and Ireland, where it also distributes a range of advanced medical technologies for infusion therapy.  In the rest of the world the Company has an established network of distribution partners around the world giving access to more than 75 countries.

The Company operates in the UK from its world-class Manufacturing and Technology Centre in Croydon, South London and from its facility in Hailsham, East Sussex, and in the USA from its facility in Melbourne, Florida.

Further information on Inspiration Healthcare can be found at www.inspirationhealthcaregroup.com

 

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