Qudits analyzed regulatory requirements for a Swiss Medtech startup seeking German DiGA fast-track approval and developed a clinical evidence concept for BfArM submission.
Situation
Analysis of the regulatory requirements to prepare a software as a medical device for a German market launch as a DiGA under the BfArM fast-track approach, with particular focus on the clinical evaluation.
Solution
Analysis of regulatory requirements for classification as a German DiGA; gap analysis of existing technical documentation and MDR change impacts; definition of mandatory deliverables including data protection, information security, clinical, safety, functionality and quality aspects; development of a clinical evidence concept.
Impact
The DiGA fast-track registration path enables medtech companies to register their software within 3 months for prescription and reimbursement. Knowledge of regulatory requirements leads to a major competitive advantage and saves time and costs.
Qudits’ role: Regulatory lead
Facts & Figures
- 4 months
- 1 consultant