ISO 14971:2019 - Does your Risk Analysis meet this new revision of the Standard?

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 14971:2019 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 ISO14971:2012, unless you are fully aware of the implications of ISO14971:2019.

Learning Objectives:

This webinar will provide valuable assistance in:

• Understanding what is new in ISO 1497:2019, Medical devices. Application of risk management to medical device
• Understanding how ISO 1497:2019 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 1497:2019 differs from ISO 14971:2012
• 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

Betty Lane
Founder and President, Be Quality Associates LLC

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 for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls including risk management, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.

Topic Background:

You may have heard that there are no new requirements in ISO 14971, 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.

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