Inspiration Healthcare Group PLC MDSAP certification
January 18 2024 - 2:00AM
RNS Non-Regulatory
TIDMIHC
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 Tel: +44 (0)330 175 0000
plc
Neil Campbell, Chief Executive
Officer
Alan Olby, Chief Financial Officer
Walbrook PR Ltd (Media and Tel: +44 (0)20 7933 8780 or inspirationhealthcare@walbrookpr.com
IR)
Anna Dunphy Mob: +44 (0) 7876 741 001
Stephanie Cuthbert Mob: +44 (0) 7796 794 663
Louis Ashe-Jepson Mob: +44 (0) 7747 515 393
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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