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...

24/06/2016 Final guidance from FDA on ISO 10993-1 and biological evaluation of medical devi...

FDA has published a final guidance on the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. The document specifically covers the use of ISO 10993-1 but also relevant to other biocompatibility standards ( other parties of I...

26/05/2016 FDA’s final guidance on Post-Market Surveillance

FDA has published a final guidance regarding post-market surveillance requirements, based on Section 522 of US Federal Food, Drug and Cosmetic Act. This final version authorizes the FDA to require post-market surveillance Plan for Class II and Class III devices, which could cause serious adverse e...

26/05/2016 Medical devices: EU reached a deal on new rules

The Netherlands presidency of the European Council and representative of the European Parliament agreed new rules on medical devices and in vitro diagnostic medical devices. The agreement, which is still subject to approval by the Council’s Permanent Representatives Committee and of the Parliament’...

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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