All Mast Group activities are conducted in accordance with our certified Quality Management System to ensure customers receive products and service to the best possible standard.

Mast Group Ltd. was first assessed against and certified to the ISO 9001 ‘Quality management systems’ standard in 1994 and is currently certified to ISO 9001 ‘Quality management systems - Requirements’, ISO 13485 ‘Medical devices – Quality management systems – Requirements for regulatory purposes’.

All products for clinical diagnostic use are CE marked.

You can find our certificates below:

We are pleased to announce that Mast Group Ltd. have been issued with our EU Quality Management System Certificate (Regulation (EU) 2017/746, Annex IX Chapter I and III), demonstrating that our Quality System meets the requirement of the Regulation.

In addition, we can now provide our partners with a copy of our Notified Body Confirmation Letter (upon request), which confirms that BSI Group The Netherlands BV, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of IVDR and has signed a written agreement with Mast Group Ltd. It clearly sets out the transition timelines that apply to the devices listed within the Notified Body Confirmation Letter that Mast Group Ltd. have committed to obtaining IVDR accreditation for.