RCS - Inspiration Health - MDSAP certification

Inspiration HealthcareAnnouncement

18/01/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240118:nRSR0520Aa&default-theme=true

RNS Number : 0520A  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: +44 (0)330
                                                                    175 0000
 Neil Campbell, Chief Executive Officer

 Alan Olby, Chief Financial Officer

 Walbrook PR Ltd (Media and IR)  Tel: +44 (0)20 7933 8780 or inspirationhealthcare@walbrookpr.com
 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 (http://www.inspirationhealthcaregroup.com)

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAGZGMMVNKGDZM