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LONDON (Alliance News) - Medical device company Inspiration Healthcare Group PLC said on Wednesday that it has been certified to the new Medical Device Single Audit Programme.
The certification will allow Inspiration Healthcare to take advantage of reduced external audits while maintaining compliance to four National Standards in Australia, Canada, Japan and the US.
The group said it is well placed to increase sales in these territories, which reflected 5.8% in total sales for the year ended January 31, 2018.
In addition, Inspiration Healthcare said it has achieved certification to EN ISO 13485:2016 for Europe, the group's largest sales region.
ISO 13485:2016 is a standard set out by the International Organization for Standardization which sets the requirements for a management system specific to the medical devices industry.
The group is currently planning to transition to the EU Medical Device Regulation by May 2020.
"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," said Chief Executive Officer Neil Campbell.
Shares in Inspiration Healthcare were up 0.1% at 65.56 pence on Wednesday.
