Requirements of the MDR Article 117 and the Impact on Product Documentation

Level Requirements Duration 1 day

Available to book: Virtual classroom €1430 Date & iscrizioni

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

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
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.
- Access to the platform where classes will be held
- Access to the platform where the materials are posted
- On successful completion of the training, participants will receive an internationally recognized certificate