Service Details
European Medical Device Regulation Consulting
We offer consulting to EU and non-EU manufacturers, authorized representatives, importers, and distributors of medical devices to ensure compliance with European regulations (MDR) for the legal placement of products on the market.
Context and Introduction
Failure to comply with applicable medical device regulations can have serious repercussions on people’s health and exposes economic operators to administrative and criminal sanctions.
For this reason, in a constantly evolving sector, it is essential to define a strategy to ensure and maintain compliance with current requirements.
01
Role Determination
We determine the category of economic operator that the organization falls under within the European medical device regulation to establish the related duties.
02
Market Placement
We identify ways to implement applicable duties to allow EU and non-EU manufacturers, authorized representatives, distributors, and importers to comply with current regulations for placing a medical device on the market.
03
Manufacturer Obligations
We support manufacturers in planning, managing, and completing the process of conformity assessment with European regulations for CE marking of medical devices.
04
Obligations of Authorized Representatives, Importers, and Distributors
We offer consulting to importers, distributors, and authorized representatives to meet registration obligations and duties related to their role, placing on the European market, and making medical devices available.
05
Training Courses
We provide customized training courses, remotely or in-person, on European regulations in the medical device sector.
Contact Us
Needs Analysis
Use the contact details in the contacts section: we can provide more details, arrange an introductory meeting, structure a tailored service, and define a dedicated economic offer.
