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 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...

31/03/2020 Commission working on proposal to postpone MDR application date for one year

On 25th March 2020, the European Commission announced that is working on a proposal to postpone the date of application for the Medical Device Regulation (MDR 2017/745) for one year. The Commission will submit this proposal in early April for the Parliament and the Council to adopt it quickly as the...

23/03/2020

On 2nd March 2020, FDA issues Final Guidance on Bone Anchor – Premarket Notification 510(k) Submissions. This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. These devices are indicated for attachment of soft tissue to bone. The final guid...

23/03/2020 Implementation of eCTD for clinical trial regulatory activities

On 19th February, Health Canada announced that has begun accepting the submissions of some clinical trial regulatory activities via electronic format. Therefore, the Sponsors may utilize the electronic Common Technical Document (eCTD) format to file clinical trial information. The use of the eCTD ...

About us

Established in 2001, Merc is a consulting 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 healthca...

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