To define this regulatory strategy, we propose meeting you to:
- Understand your project and the product(s) in development
- Decide on the qualification of the medical device or the in vitro diagnostic medical device
- Define the class of your device
- Identify the annex of the regulation for obtaining CE marking
- Identify technical standards and the associated costs that will be have to be taken into account
- Identify the innovative character of your device
- Identify needs for clinical trials
And according to your market strategy:
- Identify the countries for commercial release
- Identify the standards that will apply
It is essential to define the regulatory strategy prior to any medical device development project
REQUIREMENTS ACCORDING TO COUNTRY
