Updating the Risk Management File for EN ISO 14971:2012
Duration: 90 Minutes
The content deviations in Medical Device Directive and Risk Management Standards continue to create confusion and implementation problems. This webinar helps you analyze them and understand the connections between the MDD and the Risk Management standard. It also provides specific recommendations on how to update an existing risk management file and tips for creating a new one.
Objectives of the Presentation
Medical device manufacturers implement risk management following ISO 14971:2007. In August 2012, the European Union (EU) published a regional variation, EN ISO 14971:2012, that informs of situations where the product directives are more restrictive than the risk management standard.
While the changes has been around for some time, many companies still struggle with the changes, don’t fully understand them, and may get a nonconformance from a Notified Body.
Seven content deviations apply to the Medical Device Directive (MDD). In each case, the wording in the MDD is more restrictive than the requirements of ISO 14971:2007, so the MDD governs. Manufacturers who put the CE Mark on a medical device must bring the risk management file into compliance with the harmonized standard.
Who can Benefit
This course is for quality, regulatory, production, and design people involved in risk analysis or Risk Management for devices with a CE Mark.
Because of the cross functional and cross-discipline aspects, this is an ideal opportunity for team attendance. You need to ensure that all parties get the same message. People in the following roles can especially benefit from the knowledge in this webinar:
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Download Agenda- The substance of the seven content deviations
- An explanation of how content deviation requirement differs from the international standard
- The expected content of an ISO 14971:2007 risk management file
- Practical steps to update the risk management file to EN ISO 14971:2012
- The Team-NB recommendation for Notified Bodies to evaluate a risk management file
Medical device manufacturers implement risk management following ISO 14971:2007. In August 2012, the European Union (EU) published a regional variation, EN ISO 14971:2012, that informs of situations where the product directives are more restrictive than the risk management standard.
While the changes has been around for some time, many companies still struggle with the changes, don’t fully understand them, and may get a nonconformance from a Notified Body.
Seven content deviations apply to the Medical Device Directive (MDD). In each case, the wording in the MDD is more restrictive than the requirements of ISO 14971:2007, so the MDD governs. Manufacturers who put the CE Mark on a medical device must bring the risk management file into compliance with the harmonized standard.
Who can Benefit
This course is for quality, regulatory, production, and design people involved in risk analysis or Risk Management for devices with a CE Mark.
Because of the cross functional and cross-discipline aspects, this is an ideal opportunity for team attendance. You need to ensure that all parties get the same message. People in the following roles can especially benefit from the knowledge in this webinar:
- Risk Managers
- Validation Professionals
- Design Engineers
- Project Managers involved in Design and Development
- Quality Engineers assigned to validation activities
- Quality Auditors
- Quality staff assigned to Customer Complaints or CA&PA management