Medical technology services and consulting medical devices MERC

Navigation
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...

31/10/2018 ISO 14155 UPDATE IN 2019

The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. In general, ISO 14155 continues to cover general requirements intended to: Protect the rights and safety of human subjects; Ensure scientific conduct of clinical investiga...

07/12/2017 Main changes of the new Regulations on Medical Devices (MDR 745/2017) and on in ...

The new Medical Devices Regulations introduce changes and news compared to the current European directives for medical devices and in-vitro diagnostic medical devices. Major changes in the new Medical Devices Regulations: Increased clinical evidence: the collection and evaluation of clinical dat...

22/12/2016 New European regulations for medical devices and IVDs set to enter into force in...

European Commission officials provided an update about the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) during the Eudamed Steering Committee meeting of 14 December 2016. There have been discussions concerning the translation of the new Regulations, but the part...

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...

Contact us
I agree with the privacy policy
Digita i caratteri visualizzati nell'immagine sottostante
Ricarica
Find us