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...

19/04/2019 The FDA published a guidance for medical devices containing nitinol

The FDA published a draft guidance titled, “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol” which highlights the technical assessments to be considered for devices containing nitinol to address potential safety problems. In particular, this guidance descri...

18/04/2019 European Commission launches portal to ease transition to new two Regulations

In the editorial of the newsletter dedicated to health published by the European Commission on 12 April 2019, Timo Pesonen, the new Director General of the European Commission's Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG Grow), discusses the Medical Devices sect...

15/04/2019 New governance of medical devices presented by the Italian Ministry of Health

The Italian Ministry of Health has presented the new governance of medical devices aimed at achieving the following objectives: Optimization of governance activities, through strategic coordination of the collaborations actually entrusted to different bodies and the regulation of relations with t...

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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