Development and Processing of Medical Devices
Certification and marketing of a medical device can be a long, complex process, whether it is an improvement of a product already marketed or a new product in prototype phase. The advice we offer on Market Access is meant to make the introduction of medical devices in the European market easy.
In i2e3, we have the necessary knowledge about the requirements and processes to follow, putting it at the disposal of manufacturers, distributors and developers to enable the certification and selling of medical devices —whether a prototype, a method or technique— in compliance with European Union’s regulations. We advise our clients from the development phase of the product, and accompany them through the whole certification process.
We put our know-how at the client’s disposal, significantly reducing time and costs of the process.
WE TAKE CARE OF:
- Assessing compliance requirements according to national and European legislations governing Medical Devices and their preparation.
- Confirming the Medical Device Classification.
- Preparing the technical file for submission to the Notified Body.
- Advising on the procedure to request an evaluation of conformity.
- Advising on getting Certificates from Notified Bodies.
- Assessing safety.
- Assessing Labeling and Instructions.
- Advising on Registration of parties responsible for market placement of MD.
- Communicating distribution activities.
- Getting operation license from manufacturers.
Inquire About Your Project
For i2e3, there are no standard projects. The services we offer are modular and flexible, which allows us to choose the perfect set of actions for each case, optimizing time and available resources.