Course description
This one-days intensive course will give you a good understanding of Article 117 of the MDR and the impact that Article 117 has on the development process, the generation of documentation and the market and post-market approvals of medicinal products with an integral medical device.
It will also provide valuable knowledge to facilitate collaboration across the pharmaceutical and medical device sections within an organization.
Upcoming start dates
Suitability - 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.
Prerequisites
You should have a basic awareness of the legal framework governing the development of medicinal products.
Outcome / Qualification etc.
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
Training Course Content
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
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BSI, the British Standards Institution, is one of the world’s leading providers of training, certification, standards, regulatory approval, business improvement and management development for local and global audiences.
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