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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
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
NEW AEMPS INSTRUCTION FOR MANUFACTURING LICENSE
The new AEMPS instruction on the procedure to obtain the manufacturing licence is a long-awaited document for medical device (MD) and in vitro
Summary of Safety and Clinical Performance (SSCP/SSP)
The Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostics Medical Device Regulation (EU) 2017/746 (hereinafter referred to as MDR and
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,
A practical guide to conduct clinical investigations under the MDR
The implementation of the Medical Device Regulation (EU) 2017/745 (hereinafter referred to as MDR) has set new requirements for performing clinical
How to set up agreements to conduct a clinical investigation?
Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020,
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