Digital medical devices

Do you have a project to create a digital health product that is or will be a digital medical device (DM)? Consult our services to understand, prepare and anticipate.

6 services

Discover G_NIUS services around DM

Discover

What is a DM?

Consult the regulatory definition

2 MIN

DISCOVER

Diagnosis: is my solution a DM?

Determine whether your solution is a DM or not

10 MIN

ECOSYSTEM

Who are the DM players?

Identify the players involved in the DM process

5 MIN

REGULATORY

4 questions to prepare my DM for the market

Anticipate the key steps to market access

5 MIN

REGULATORY

CE marking: where to start?

Define your regulatory strategy

10 MIN

FINANCING

4 questions to anticipate the reimbursement of my DM

How do I get reimbursed by the French health insurance system?

5 MIN

Project Director at the Ministry of Health and Prevention for the Digital Health Acceleration Strategy (SASN)

A word from Aymeric Perchant

Companies launching into medical devices, particularly digital ones, face a number of challenges. Beyond research and development, the first step to take concerns the quality and regulatory approach. It is essential to build a regulatory strategy from the earliest stages of product development, in line with one's company's objectives. Regulations can be used as a complete and effective guide to bringing a safe, high-performance medical device to market for users, and should not be seen (solely) as a constraint.

Find out more about the medical device?

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