Blog & updates
Insights, case studies and news from the world of Regulatory Affairs.
THE MEDIQUASAR BLOG
The MediQuasar blog features technical articles, practical guidance and updates across MDR, IVDR, quality and regulatory pathways.
Our content is clear, reliable and current—created to help companies and professionals make informed decisions in a fast-changing sector.
All articles are original contributions from MediQuasar, grounded in hands-on experience and continuous monitoring of regulations, guidance and best practice.
Disclaimer:
The information provided is not intended as advice for individual cases. It is shared for general informational and training purposes.
Insights
In-depth articles
A curated collection of technical resources and informational updates to help you stay aligned with the regulatory and procedural requirements governing European markets.
MDCG guidance: what it is and why it is essential
MDCG (Medical Device Coordination Group) guidance documents are official EU publications that support the practical interpretation of the MDR/IVDR. They are not legally binding, but they represent a key technical reference for manufacturers, notified bodies and other...
MDR 2017/745: a clear overview of the European Medical Devices Regulation
Regulation (EU) 2017/745 (MDR) is the legal framework that governs all medical devices placed on the European market today. Fully applicable since 26 May 2021, it replaced Directive 93/42/EEC (MDD), introducing significantly more stringent requirements in terms of...
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