On 28 January 2022, Regulation 2022/112 entered into force, amending the transitional provisions in Article 110 of the (EU) 2017/746. As a result,
When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed,
Madrid, 24th August 2022 - We are pleased to announce that AKRN, Now part of NAMSA, is now ISO 9001:2015 quality certified by EQA, a recognized
The new AEMPS instruction on the procedure to obtain the manufacturing licence is a long-awaited document for medical device (MD) and in vitro
Previously, we published an article introducing the basic concepts, definitions and requirements for Quality Management Systems (QMS) within the
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