Dr Peer Schmidt, AbbVie Deutschland GmbH & Co. KG, Germany
With the application of the Medical Device Regulation (MDR) in May 2020 and the regulation about in-vitro diagnostics, the topic risk management will gain further importance for medical devices and IVDs. Risk management is the „backbone“ during development, manufacturing and market surveillance of these products. Quality risk management is essential throughout the whole life cycle of a medical device. The risk management file is key for the description of product risks, their control, acceptance and monitoring. ISO 14971 represents the “state of the art” as an “implementation standard” but is being revised and currently available as a draft. ISO 13485:2016 also addresses the topic of risk management. In the pharmaceutical world, however, quality risk management follows ICH Q9 . In the case of combination products, both perspectives must be observed and a risk management file must be kept for the medical devices element.
The webinar is intended for manufacturers who want to stay on top of the requirements for quality risk management for Medical Devices, especially developers, quality assurance, engineers and Regulatory Affairs. It also applies to drug manufacturers utilizing medical devices to administer their products (combination products). Finally, consultants in the Risk Management field are addressed.
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The topics addressed are:
- Regulations overview: ICH Q9, ISO 14971, ISO 24971, MDR - similarities & differences
- Outlook: revision of ISO 14971
- US vs. EU requirements
- Focus on the patient
- Compliance or business reasons?
- Best Practice: Risk Management File, CQA and Risk - tools: FMEA, Risk Matrix, hazard analysis, etc.
- Responsibilities regarding cross-contamination according to EU GMP chapters 3&5
- How do complaints, exceptions, planned changes etc., impact residual risk?