Medos

EU MDR IVDR FDA Clinical Evaluation Cybersecurity

Medos is a Linköping-based medical technology consultancy supporting device companies from product development through market clearance and growth. Its regulatory services cover CE marking, MDR, IVDR and FDA requirements, alongside ISO 13485 quality management, risk management and clinical evaluation. The company has particular experience in medical-device software and also provides information-security and cybersecurity support for regulated products.

Learn more

Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

MDCG guidance

MDCG 2025-4: Medical device software apps on online platforms

How MDR/IVDR and Digital Services Act responsibilities apply when medical device software apps are offered through app stores and online platforms.

Software Endorsed Jun 2025

SaMD : Is the frontend part of the medicla device under EU MDR ?

Anonymous

8 months ago

In a CE-marked SaMD under EU MDR, only the backend of our software performs the medical function (clinical data processing, rule evaluation, alert generation). The frontend performs no medical logic a

No answers yet