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...

21/09/2020 New UK registration requirements and UKCA mark

From 1 January 2021, there will be new MHRA registration requirements indicating how medical devices will be placed on the UK market. It is safe to say that the requirements are phased in depending on the risk class. Below there’s an indicative time frame for the specific classes: 4 months: Class...

21/09/2020 Vigilance on Medical Devices

The Report on medical devices Vigilance activities was published by the Italian Ministry of Health to share with all those involved in the medical devices sector the data obtained from the analysis of Vigilance activities, in order to ensure the circulation of safe medical devices to be used by pati...

01/09/2020

The US FDA has included revised quality standards in their Spring 2020 Agency Rule List in order to align with ISO 13485:2016. The FDA has initially proposed to revise the Quality System Regulations (QSR) as to provide simpler medical device market pathways in order to obtain 510(K) premarket noti...

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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