The founders of Merc have been dealing with medical device manufacturing and distribution since the early nineties. We have developed a strong experience both in Europe, and overseas.
Our experience areas include:
- Peripheral and Vascular disease
- Renal Disease
We have been directly involved in all phases of medical device development, including design, production, clinical trials, First In Man studies and observational registries. We can understand your needs, and thanks to our global network, we can offer you support either locally, or worldwide.
Below are some of the services we provide:
- Preliminary evaluation of Regulatory strategies.
- Identification of the best regulatory strategy to reach the market in the easiest/fastest way.
- Proposal of different regulatory strategies with pros and cons.
- Preparation of a Technical File to prove compliance with the Medical Device Directive (or the IVD/AIMD Directives)
- Submission of the technical file to a Notified Body and obtaining of a CE-Mark certificate for medium- or high-risk devices
- Designation of an Authorized Representative for customers with no physical location in Europe
- Registration of medical devices with the Competent Authorities in the different European Countries (Class I, device national notification)
- Development and Maintenance of a Post-market Surveillance System according to the MDD and to the legislation of each country.