Strategic-regulatory consultancy

Strategic-regulatory consultancy

Medical Consulting S.r.l.s., through its adequately trained and specialized staff, carries out strategic-regulatory consultancy activities to assist and support Organizations in the medical sector in the process of continuous improvement and in accessing the markets of Major Countries.

The services offered include:

• Definition of the regulatory marketing strategy and feasibility analysis for marketing in the country of interest.
• Quality Technical Agreement (QTA) drafting with distributors, importers and local representatives.
• Conducting audits, pre-audits and gap analysis to verify compliance of the QMS with the requirements of the country of interest

That’s what we deal with in detail

Analysis and initial technical evaluation

We evaluate the preliminary project for a device, focusing on its strengths and weaknesses. We suggest modifications and, if requested, we produce the first prototypes

Strategic market consulting

Analyses of any eventual competitors, benchmarking and assessment of the national and international real market potential of a medical-surgical device and/or implant

Selection and partner coordination

Consulting anticipates the selection and coordination of partners equipped with the best skills necessary to turn the project into a reality.