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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
What is good clinical practice (GCP)?
Good clinical practice (GCP) GCP is an international quality standard that governments can transpose into regulations that decide how clinical
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,
FELLOW PROGRAM – THE TALENT INCUBATOR OF A CRO
In the September edition of the scientific magazine PMFarma, you can read about our Company-funded professional training program for young scientists
AUDITING A QMS ACCORDING TO ISO 13485
When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed,
Clinical Performance Study applications for IVDs in Spain
In vitro diagnostic medical devices (IVDs) are increasingly in demand as the medical technology evolves by leaps and bounds. With the application of
EU MDR risk management requirements: FMEA and ISO 14971 comparison
Historically, medical device manufacturers have frequently used Failure Modes and Effects Analysis (FMEA) to identify possible failures in
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
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