Service features

Conformity to medical devices regulation

We help ensure manufacturers, distributors and importers comply with the regulation applicable to medical devices (MDR, harmonised standards and national legislation). Specifically, we set out strategies and guidelines for CE marking, market entry, and after-sales management.

Context and introduction

Not complying with the regulation applicable to medical devices can result in serious legal sanctions.
That’s why, in a continually evolving industry, it’s crucial to draw up a planning, production, certification, sales, and after-sales management strategy alongside constant support that ensures full conformity with the current requirements.

01

Drawing up a strategy

We classify the medical device, establish the best strategy for CE marking, provide realistic timeframes to obtain marking, and set out an approach to complying with the applicable legislation standards.

02

CE marking for medical devices

We manage the entire MDR-based CE marking process for new devices, as well as approval for modifications to products with existing markings. We also look after the relationship with notified bodies.

03

Placing on the market

To help manufacturers, distributors and importers to respect current regulation, we set out the requirements applicable in the nations where the medical devices are sold (including non-EU countries) and provide consultancy to comply with them.

04

Surveillance and vigilance

We monitor the market for updated standards, look at scientific literature and seek out negative outcomes involving similar medical devices in international databases. On completion, we support clients in managing incidents, non-conformity, complaints, and recalls.

05

Change management

We set out the impact of modifications to the product and the process, and the best strategy to manage them. We also manage adapting documentation and approval from the notified body.

Contact us

Requirement analysis.

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