Risk Management for Medical Devices per ISO 14971 2019

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Risk Management for Medical Devices per ISO 14971 2019

September 20, Wednesday 10:00 AM PDT | 01:00 PM EDT Duration: 60 Min

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ISO 14971:2019 has introduced significant changes including benefit, reasonably foreseeable misuse and state of the art, as well as the management of risks associated with medical devices. It is important to be aware of these changes as technology continues to emerge.

Why Should You Attend:

If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.

Areas Covered in the Webinar:

  • Risk management process as per ISO 14971.
  • Management responsibilities
  • Qualification of personnel
  • Risk management plan
  • Risk management file
  • Bringing it all together – links to design and process

Instructor Profile:

    Jose Mora
    Principal Consultant, Atzari Enterprises

    José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.