BSI’s Medical Device Software with Cybersecurity one-day training course has been designed to provide you 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.
This course involves practical activities, group discussions and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance.
How will I benefit?
This course will help you to:
- 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 or preparation of documentation to support the medicines integrated in the medical device. For example: Regulatory Affairs, (Chemistry, Manufacturing and Controls (CMC)), QA, clinicians and project managers.
Prerequisites
You should have a basic awareness of the legal framework governing the development of medicinal products.
What will I learn
This course will help you to:
- 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
What's included
- Training course notes
- An internationally recognized BSI certificate
Course Guide
