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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,
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),
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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