Regulatory Diagnosis

To clarify your strategy and increase efficiency

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innovative healthcare startups and project leaders

MD101’s regulatory diagnosis enables you to define the regulatory status of your product and the impact of regulations on its market.

Our regulatory diagnosis enables you to:

  • Identify the main applicable regulatory texts and standards.
  • Establish the applicable CE and FDA marking procedures.
  • Classify and justify the class of your device according to EU regulation 2017/745 or EU 2017/746 and FDA.
  • Understand the main regulatory and standards requirements you need to comply with.
  • Establish a regulatory roadmap to obtain CE marking and FDA clearance. It is important to define your regulatory strategy clearly, so that you can draw up a schedule and a realistic business plan to answer your potential investors’ questions.

 

MD101, co-founder of the .emt Alliance

United to support companies in HealthCare

MD101, co-founder of the .emt Alliance

MD101, founding member of The MedTechAlliance, USA

Catalyzing global growth and innovation

MD101, founding member of The MedTechAlliance, USA