Inspiration Healthcare Group PLC Certification received to the new MDSAP
March 20 2019 - 3:02AM
RNS Non-Regulatory
TIDMIHC
Inspiration Healthcare Group PLC
20 March 2019
Inspiration Healthcare Group plc
("Inspiration Healthcare", the "Company" or the "Group")
Certification Received to the new
Medical Device Single Audit Programme
(MDSAP).
Inspiration Healthcare Group plc (AIM: IHC), the global medical
device company, is pleased to announce that Inspiration Healthcare
Ltd, has been certified to the new Medical Device Single Audit
Programme (MDSAP). This allows the Company to take advantage of
reduced external audits whilst maintaining compliance to four
National Standards in the following jurisdictions: Australia,
Canada, Japan and the USA. It positions the Company well to
increase sales to these territories going forward which in FY2018
represented 5.8% of total sales. At the same time the group
achieved certification to EN ISO 13485:2016 for Europe, currently
the group's largest international sales region.
The Company is already advancing its plans to transition to the
EU Medical Device Regulation by May 2020.
Commenting, Neil Campbell, CEO said
"We are pleased to have been given this certification today,
which involved a time consuming process to align our quality
management system to this new auditing framework, and means we can
continue to develop sales in these important markets. Obtaining
certifications for our products is a very challenging process and
in the last year we have significantly improved our capabilities in
this area by investing in highly experienced people. The constantly
changing regulatory environment necessitates that we continue to
invest in this aspect of our business."
Enquiries:
Inspiration Healthcare Group Tel: 01455 840555
plc
Neil Campbell, Chief Executive
Officer
Mike Briant, Chief Financial
Officer
Nominated Adviser & Broker Tel: 0207 397 8900
Cenkos Securities plc
Mark Connelly
Cameron MacRitchie
-------------------
Cadogan PR Tel: 07771 713608
Alex Walters
-------------------
About Inspiration Healthcare
Inspiration Healthcare (AIM: IHC) is a global supplier of
medical technology for critical care, operating theatre and other
medical applications. The Company provides high quality innovative
products to patients and caregivers around the world that help to
improve patient outcomes and efficiencies of healthcare
organisations with patient focused customer service and technical
support.
The Company's own brand of critical care solutions span
non-invasive respiratory management, thermoregulation and
diagnostics, and patient warming for newborns through to adults in
intensive care and the operating theatre, whilst the distribution
business supplies solutions to support specialised surgical
procedures and infusion therapies.
Present in over 50 countries worldwide, Inspiration Healthcare's
success has been built on continuous innovation, excellent customer
service and an inherent commitment to improving the quality of life
of patients, working in close collaboration with key opinion
leaders and stakeholders in the clinical and medical community
across the globe.
Further information on Inspiration Healthcare can be seen at
www.inspiration-healthcare.com
About MDSAP
The Medical Device Single Audit Program (MDSAP) allows a single
audit of a medical device manufacturer's Quality Management System
which satisfies the requirements of multiple regulatory
jurisdictions.
International partners that are participating in the MDSAP
include:
-- Australia - Therapeutic Goods Administration of Australia
-- Brazil - Agência Nacional de Vigilância Sanitária
-- Canada - Health Canada
-- Japan - Ministry of Health, Labour and Welfare, and the
Japanese Pharmaceuticals and Medical Devices Agency
-- USA - The Food and Drug Administration (FDA)
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END
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March 20, 2019 03:02 ET (07:02 GMT)
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