Turn regulatory uncertainty into a clear, actionable strategy aligned with Regulation (EU) 2017/745. The Regulatory Strategy template gives manufacturers a clear, documented plan for achieving and maintaining market access under Regulation (EU) 2017/745.
It guides manufacturers through every critical decision point in the regulatory process, covering:
- Device classification, equivalence considerations, and conformity assessment selection
- Quality management system and general safety and performance requirements
- Technical documentation, including device description, design and manufacturing information, risk management, and product verification and validation
- UDI assignment, Declaration of Conformity, and CE marking
- Post-market activities and management of device modifications
By consolidating all elements of the regulatory approach into a single, structured document, manufacturers can ensure that compliance activities are proactively planned, effectively coordinated, and consistently executed throughout the device lifecycle.
This template provides medical device manufacturers with a complete and coherent regulatory roadmap from the outset—supporting informed decision-making, reducing uncertainty, and enabling a more efficient path to compliance.
Price: $150
