Device – Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process
Reduce risk, avoid mistakes and speed up compliance with EU Medical Device Directive (MDD) regulations by completing Device-Drug Combinations: Borderline Issues and Consultation Process Guidance. This one day training course is designed to help device-drug manufacturers prove products are safe for market.
If you work with ancillary medical substances or derivatives of human blood or plasma, we can help you remove all uncertainty from the consultation process. We will outline ISO 13485:2003 and EU MDD requirements, allowing you to establish realistic timescales and avoid common errors that can cause delays and working with our experts, you can be confident of ISO 13485:2003 and EU compliance.
The course is recognised by the Medicines and Healthcare products Regulatory Agency.
Who should attend?
- Those working in regulatory affairs, research and development
- Consultants and project managers
- Anyone involved in the product to market process.
“The tutor undertook the course with enthusiasm, and allowed each group member to provide input into the day.”
What will I learn?
- Understand all aspects of the classification process
- Get to grips with all requirements of the classification process
- Classify medical devices and medicinal products
- Lead a product team in planning timescales and avoiding errors
- Interpret consultation document requirements
- Evaluate changes and ensure ongoing compliance.
How will I benefit?
- Overcome challenges in gaining ISO 13485:2003 and EU MDD compliance
- Manage risk and improve the product to market process
- Increase customer confidence with proof of product safety
- Build business success with European market access
- Build a culture of risk awareness and understanding around compliance.
- Attendance on this course will provide delegates with 8 CPD points.
- Training course notes