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...

27/09/2016 FDA has released a draft guidance document - Coordinated Development of Antimic...

The U.S. Food and Drug Administration (FDA) has released a draft guidance document entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” This document is intended to help drug sponsors and device manufacturers coordinate the development of new anti...

21/09/2016 FDA Draft Guidance on software changes: tips on how to be compliant with regulat...

FDA has published a new draft guidance regarding software changes into an existing device. This document is the result of Agency decision to separate software changes regulations from other devices. This guidance shows FDA commitment in acquiring better awareness on issues related to software produ...

18/08/2016 Final FDA Guidance on Medical Device Electromagnetic Compatibility (ECM)

FDA has finalized a guidance on how manufacturers of electrically powered devices should prove Electromagnetic Compatibility for premarket clearance and approval. Electrically powered devices include those that are battery powered and active implantable devices. According to this guidance Electro...

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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