Webinar: Medical Device Technical Documentation – changes caused by MDR
Course No 18215
Important: Deadline is 12 noon on 8 March 2021
If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Gerhard Bauer-Lewerenz, Bauer-Lewerenz Consulting, Bad Homburg, Germany
Background
Since the introduction of the medical device regulation in the 90ies, the Technical Documentation had a central role in medical device compliance. It is the basis for conformity assessment and therefore essential for the marketing of the product. The still effective Medical Device Directive specifies only a few concrete requirements regarding the content of the Technical Documentation. A Notified Body recommendation, which is more specific, dates back to 2000.
The Medical Device Regulation (MDR) now specifies the requirements for the Technical Documentation in much detail in Annex II. Annex III then addresses the Technical Documentation in the context of Post Market Surveillance (PMS). Due to postponement of the effectiveness of the MDR to 26 May 2021, there is now one more year to comply with these new requirements.
Target Group
This webinar is intended for employees from medical device/combination product companies, who are involved in the creation and/or maintenance of the Technical Documentation. Of course, consultants in this field, who want to get information from the view of the medical device industry, are also addressed.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
Due to the new Medical Device Regulation and its Annexes II and III, new requirements regarding the Technical Documentation(TD) of medical devices are also coming up. During the webinar, the TD will be addressed within in the context of the product life cycle - from development to post-market surveillance and market discontinuation. This comprises:
- Goals for the Technical Documentation
- Special issue: Grouping of medical devices - Content of the TD according to the Medical Device Directive
- Content of the TD according to the Medical Device Regulation
- Changes / How to handle legacy products - The SOP „Technical Documentation“
- Content, creation, control, review - Key components of risk management and risk analysis
- Documentation of design – product design and development process
- The TD in Post Market Surveillance
- Tasks of the responsible person regarding the TD
- The TD in audits
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