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...

07/02/2020 Call for applications: observers for the Annex XVI sub-group of the medical devi...

The European Commission issued a call for applications from stakeholder associations to select observers to the Annex XVI sub-group of the medical devices coordination group (MDCG). The Annex XVI lists the groups of products without an intended medical purpose to which the regulation 2017/745 appli...

07/02/2020 Clinical Performance Assessment: Considerations for CADe Devices Applied to Radi...

On 22nd January 2020, FDA published a guidance for premarket approval (PMA) and premarket notification (510(k)) submissions for Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data. This guidance document provi...

31/01/2020

GreenBone Ortho, one of the most innovative Start-up in the Italian biotech scene, has obtained the CE mark for its bone substitute, a biomimetic material derived from the transformation of Rattan through a technological process developed and patented by the company. GreenBone Bone SubstituteTM has...

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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