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Artificial Intelligence challenges in Medical Devices
Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used
Drug or Device? Summary and analysis of MDCG 2022-05 on borderline products
Introduction In Europe, the commercialization of healthcare products is highly regulated. While medical devices are marketed according to EU
TRANSITIONAL PROVISIONS according to (EU) 2017/746 ARTICLE 110 IVDR, AN UPDATE WITH MDCGs published in 2022.
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,
ÅKRN IS NOW ISO 9001 QUALITY CERTIFIED
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
Roadmap to CE marking for medical devices and IVDs
Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the
The quality management system according to ISO 13485
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall “establish, document,
Safety reporting for clinical investigations under the MDR
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
Progressive roll-out of the IVDR: extended timelines for certain IVDs
By the end of 2021, the European Parliament adopted the proposal of the European Commission to amend the EU 2017/746 in vitro diagnostic medical
What is CE marking and do all products need CE marking?
Not all products sold in the European Union (EU) need to bear CE marking. CE marking is only mandatory for those products that fall under
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