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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
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
DEVELOP AND IMPLEMENT YOUR QMS ACCORDING TO ISO 13485
Previously, we published an article introducing the basic concepts, definitions and requirements for Quality Management Systems (QMS) within the
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
Essential documents according to ISO 14155:2020
A typical consultation we receive at AKRN Scientific Consulting is related to the essential documents required for planning, conducting and closing
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,
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