Last checked at 20 Mar 2019 07:00
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 plc Neil Campbell, Chief Executive Officer Mike Briant, Chief Financial Officer | Tel: 01455 840555
|
Nominated Adviser & Broker Cenkos Securities plc Mark Connelly Cameron MacRitchie | Tel: 0207 397 8900
|
Cadogan PR Alex Walters | Tel: 07771 713608 |
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)