This course is designed to provide you with an understanding of the requirements of Article 117 and the impact of these requirements on the documentation needed to obtain market approval and post-market approvals for medicinal products with an integral medical device.
It will also provide you with a general overview of the new Medical Device Regulation (MDR 2017/745) and of the activities involved in demonstrating conformity with the relevant general safety and performance requirements of a medical device.
Practical activities throughout the day will give you the opportunity to test your new knowledge and to discuss relevant scenarios with the other delegates.
How will I benefit?)
This course will help you:
- Obtain basic knowledge of the MDR
- Be familiar with the key activities involved in demonstrating conformity with the relevant GSPRs for a medical device
- Determine whether Article 117 is applicable to your product
- Outline an overall documentation strategy for a medicinal product used with a medical device
- Help and guide your organization in the development and preparation of documentation for medicinal products with an integral medical device
Who should attend?
Anyone involved in the planning of or preparation of documentation to support medicinal products with an integral medical device. For example,
Regulatory Affairs, (Chemistry, Manufacturing and Controls (CMC)), QA, Clinical and Project Managers.
What will I learn?
After completing this training course, you’ll be able to:
- Appreciate the background and content of the Medical Device regulation (MDR)
- Identify the classification of medical devices
- Explain the General Safety and Performance Requirements (GSPRs), at a high level
- Interpret the meaning and requirements of Article 117 of the MDR
- Identify the impact of Article 117 on the planning and preparation of Marketing Authorization Approvals (MAAs) for medicinal products with an integral medical device
- Facilitate collaboration between the pharmaceutical department and the medical device department within your organization
What is included?
- On completion, you'll be awarded an internationally respected BSI Training Academy certificate
- Detailed course notes
- Lunch and refreshments
- Loan copy of the standard (to be returned after the course)
Contact us
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com
