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

Betty Lane

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This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.

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) you must be aware of what is new in ISO 14971:2012 or you could face delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.

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. The stricter interpretations will be expected during ISO 13485 audits and Technical File and Design Dossier document review. You cannot be comfortable 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.

Learning Objectives:

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) CE Mark
  • Knowing what you have to do to update your Risk Analysis for continued MDD Compliance
  • How to update your Risk Management process to ensure continued MDD compliance

Areas Covered in this Webinar:

  • 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 Will Benefit:

This webinar will provide valuable assistance to:

  • Medical Device Quality Management
  • Medical Device Regulatory Affairs
  • Medical Device Quality Engineers
  • Medical Device Design Engineers
  • Compliance managers
  • Quality auditors in medical device companies
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

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Speaker: Betty Lane,

Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP.




Get in touch

(315) 632-0735,
(315) 750-4379

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212-751-3500