Medical technology services and consulting medical devices MERC

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...

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...

04/11/2016 FDA Adopts Proposals by the IMDRF for the Clinical Evaluation of Software as Med...

The proposals by the International Medical Device Regulators Forum (IMDRF) regarding the clinical evaluation of software as a medical device have been incorporated into a new draft guidance by the US Food and Drug Administration. In a document issued in August 2016, the IMDRF proposed some specifi...

19/10/2016 UDI requirements for “Convenience Kits” revised by FDA

The US FDA has changed the definition of “convenience kits” -two or more medical devices packaged together- in terms of Unique Device Identification (UDI) requirements. According to the new draft guidance, a convenience kit consists of two or more devices sold in a single package for convenience; ...

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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