Digital medical devices

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

6 services.

Discover G_NIUS services related to medical devices

Discover

What is a Medical Device?

See the regulatory definition

2 MIN

DISCOVER

Diagnosis: Is my solution a medical device?

Determine whether your solution is a Medical Device or not

10 MIN

ECOSYSTEM

Who are the players in the medical device industry?

Identify the stakeholders involved in the change management process

5 MIN

REGULATIONS

4 questions to prepare my medical device for the market

Anticipating key steps in market access

5 MIN

REGULATIONS

CE marking: where to start?

Define your regulatory strategy

10 MIN

FINANCING

4 questions to anticipate reimbursement for my medical device

How can I get reimbursed by French health insurance?

5 MIN

Coordinator of the "Digital health" acceleration strategy (SASN) and Head of the Skills, Innovation, and Research Division at the Digital Health Delegation (DNS)

A word from Aymeric Perchant

Companies entering the medical device market, particularly in the digital sector, face many challenges. Beyond research and development, the first step is to address quality and regulatory issues. It is essential to develop a regulatory strategy from the early stages of product development, in line with the company's objectives. Regulations can be used as a comprehensive and effective guide for bringing a safe and effective medical device to market for users, and should not be seen (solely) as a constraint.