Medical technology services and consulting medical devices MERC

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Customer Solutions

Regulatory Affairs and Clinical Issues, Marketing e Commercial, related to Medical Devices.

Regulatory Processes

Definition and Support of Regulatory strategies for product approval during design and development

Market Access

Support with the definition of Marketing Strategies for new and existing products with identification of market segments and distribution models

Clinical Support

Development and Implementation of Clinical Strategies for Medical Devices, including a specific approach for First In Man Studies

MERC - International Medical Technology Services

Merc is a consulting medical devices company acting in the field of medical devices.
With our extensive experience in the medical device industry, we offer you knowledge and support in all the different aspects of the Market Access of a new product, from regulatory requirements to distribution definition at an International level.

Our core competencies include all activities related to the medical device life cycle from the product development to the market and post-market surveillance as well as medical technology services.

Medical Technology Services

We provide companies with a global regulatory strategy for product and technology development, quality system compliance, clinical trial consulting, i...

22/12/2016 New European regulations for medical devices and IVDs set to enter into force in...

European Commission officials provided an update about the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) during the Eudamed Steering Committee meeting of 14 December 2016. There have been discussions concerning the translation of the new Regulations, but the part...

21/12/2016 Mexico’s COFEPRIS allows Third Party Reviewers (TPRs) to access stalled medical ...

The Mexican health authority COFEPRIS has started to allow Third Party Reviewers (TPRs) to access premarket registrations that have stalled under the standard review system. After obtaining authorization from a Mexico Registration Holder (MRH), TPRs may review their registration applications and th...

25/11/2016 French Competent Authority ANSM provides indications for manufacturers whose Not...

New recommendations and procedures for manufacturers whose Notified Bodies terminate CE certification and auditing support have been issued by the French National Agency for the Safety of Medicines and Health Products (ANSM). Such manufacturers may obtain marketing extensions for their devices unt...

About us

Established in 2001, Merc is a medical device company specialized in Medical Devices. Co-founders Elena Venturelli e Michele Maltese have experience in production and distribution of medical devices and therapy development, with roles in the framework of Regulatory, Quality Assurance, Clinical processes and Marketing. We can provide a link between the Medical Industry, Health Care Authorities, Distributors and Physicians, taking care of all procedures involving national, regional and local heal...

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