Introduction In Europe, the commercialization of healthcare products is highly regulated. While medical devices are marketed according to EU
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,
In the September edition of the scientific magazine PMFarma, you can read about our Company-funded professional training program for young scientists
When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed,
In vitro diagnostic medical devices (IVDs) are increasingly in demand as the medical technology evolves by leaps and bounds. With the application of
Historically, medical device manufacturers have frequently used Failure Modes and Effects Analysis (FMEA) to identify possible failures in
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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