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...

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 According to the new draft guidance, a convenience kit consists of two or more devices sold in a single package for convenience; ...

10/10/2016 Final rule for clinical trial information Reporting in the US

In September 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies how to submit information related to clinical trials on, in accordance with FDAAA 801. The final rule specifies which trials must be submitted, when they must be submitted, and w...

03/10/2016 FDA Extends UDI Deadline for Convenience Kit and Repackaged Device Labelers

Labelers of some Class II devices have been notified by the FDA that their deadline for Unique Device Identification (UDI) compliance has been extended to September 2018. The new compliance date for UDI labeling, as well as Global Unique Device Identification Database (GUDID) compliance, is Septe...

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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