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Regulatory Intelligence per dispositivi medici

Feasibility studies and Regulatory Intelligence for medical devices

Regulatory Intelligence can be defined as information analysis and generation of valid results to support regulatory strategies and business decisions. Data collection can be carried out by using databases, websites, literature and much more. However, source selection as well as information collection and analysis should be carried by professionals with a high level of experience in this field, with a clear search target, and able to provide their recipients with critical and strategic support.

Thanks to the availability of many professionals, Di Renzo Regulatory Affairs offers assistance to companies, carrying out:

  • strategy advice and check of the feasibility of company projects, with indications on the product regulatory framework, classification, requirements to be met, costs
  • regulatory updating on the areas of interests
  • advice on the national, EU and extra-EU (for specific countries) legislation
  • Due Diligence and check of the conformity of the product technical documentation to the EU and national requirements applicable
  • Gap Analysis on the documentation and company’s status as regards the Regulations (EU) 2017/745 and 2017/746
  • support in handling the transition to Regulation (EU) 2017/745 (MDR)
  • advice on borderline medical devices
  • business training courses.

Foto di orzalaga da Pixabay