Medical Devices Directive

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We provide companies with a global regulatory strategy for product and technology development, quality system compliance, clinical trial consulting, in-country representation and distributor qualification.
We are in touch with several European companies working on advanced technologies for the implementation of new Medical Devices.
Since our network of relationships includes research centers and universities willing to collaborate with industries , we can easily create opportunities for new projects.
We can have product acceptance evaluated by leading experts in all specific therapeutic areas, in order to identify the real unmet needs and the best business model for your products (hospital departments, distributions channels, etc.), helping you find the easiest and fastest market access strategy for your products.
We can approach the right KOLs in the early stages of a project and  involve them in project evaluation.
Merc support its customers in defining a regulatory strategy for product approval and in the different design and development phases. We work together with our customers to find the best regulatory path for a successful access to European and International Markets.

We can review your existing data, arrange them in order to meet all requirements, and assist you in completing the most critical areas of your files, such as:

  • Identification of the Essential Requirements
  • Identification of the Harmonised Standard
  • Risk Management
  • Biocompatibility test Plan
  • Quality System Procedures
  • Clinical Evaluation
  • Gap analysis of your technical files according to the New Directive 2007/47/EC

Whether you are based in Europe, or in any part of the world, Merc will support you with the development and implementation of a post-market surveillance system and with all reporting activities.

Merc will assist you through the notification process and answer all your questions about national and international registrations.

Merc can act as an independent regulatory representative in Italy and Europe.

By providing custom solutions based on product type and geographical area, Merc will support the development of your Quality System according to the existing international standards.

We can help your company achieve certification and compliance with the European and International standards:

  • ISO 13485 Quality System Standard, specifically designed for medical devices.
  • European Medical Devices Directive
  • U.S. FDA Quality System Regulations
  • Canadian Medical Devices Regulation

 

We can perform internal, supplier or pre-inspection audits in order to verify the correct implementation of your Quality System according to your procedures, or to any Standards/Directives.

We can also conduct diligence audits in case of internal reorganization, acquisition and/or merging.

Merc provides full support with the development and implementation of  clinical strategies for medical devices, including a specific approach for First In Man Studies. We also assist sponsors in selecting, managing and monitoring study sites in order to optimize times and costs.

Merc will assist you with the Clinical Evaluation of your products, assisting you with all activities related to the management of Clinical Studies.

Thanks to our profound knowledge of medical device technologies and to our contacts with European providers of innovative medical solutions, we are able to find the best suppliers for the products and services you need.