40 2014 - ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements

Instructor: Betty Lane
Description:
This presentation will provide information on how to review your current risk analysis to make sure you fully comply with the requirements for Risk Analysis under EU Directive 93/42/EEC on Medical Devices and the other European Medical Device directives. The stricter interpretations will be expected during ISO 13485 audits and Technical File and Design Dossier document review starting in 2013. You cannot depend that you can meet these requirements just because your current risk analysis meets ISO14971:2007, unless you are fully aware of the implications of ISO14971:2012.
You may have heard that there are no new requirements in ISO 14971:2012, Medical devices - Application of risk management to medical devices, and that is true. However, the new informative annexes provided describe the relationship between complying with the requirements of ISO 14971 and the stricter requirements of the European medical device directives. This session will focus on those requirements for compliance to the MDD, EU Directive 93/42/EEC on Medical Devices, but will also cover how to comply with stricter requirements related to AIMDD, IVDD directives as well.
Why Should you Attend:
If you have or plan to have a CE mark under European Union Directive 93/42/EEC on Medical Devices (MDD) or other European Medical Device directives you must be aware of what is new in ISO 14971:2012 or you could face delays in obtaining or maintain your CE mark for compliance to the Medical Device Directives.
This webinar will provide valuable assistance in:
Understanding what is new in ISO 1497:2012, Medical devices. Application of risk management to medical device
Understanding how ISO 1497:2012 impacts your Medical Device Directive (MDD, IVDD, AIMDD) CE Mark
Knowing what you have to do to update your Risk Analysis for continued European Medical Device Directives Compliance
How to update your Risk Management process to ensure continued European directive compliance and a valid CE mark
Objectives of the Presentation:
What is ISO 14971
How ISO 1497:2012 differs from ISO 14971:2007
How to update your Risk Analysis to meet continued compliance to the European Medical Device Directive(MDD)
How to make sure your Risk Management procedure assures you can meet your CE mark requirements for Risk Analysis
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
Quality Management
Regulatory Affairs
Quality Engineers
Design Engineers
Compliance Managers
Quality Auditors
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