Regulatory Strategy

Isocèle Conseil helps you to define the regulatory strategy for your products.

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