Understanding ISO 14971:2012: Changes to Annex Z and Impact on the Risk Management File

Duration: 60 Minutes
ISO 14971 has long been the gold standard of risk management for medical device companies. Recently, several changes to Annex Z have been implemented in the 2012 revision which otherwise may go unnoticed but which have significant impact to the risk management file.
Understanding ISO 14971:2012
Instructor: David Amor
Product ID: 500369

Learn about the discontinued support of the ALARP principle and how to address negligible risks, new requirements surrounding risk benefit analyses and mitigation strategies for risks that don’t include labeling. This discussion will use case studies to create a practical approach to modifying or creating your risk management file.

Why Should you Attend:
Risk management is a key part of a medical device design history. It is critical documentation that is often inspected and audited as part of regulatory body reviews. The number of 483s and warning letters associated with risk management are increased due to difficulty for companies to interpret ISO 14971:2012 and implement it appropriately.

Objectives of the Presentation:
  • Highlight key changes to ISO 14971:2012
  • Review Annex Z change impact to current risk management strategies
  • Learn how to update your risk management file to comply
  • Review case studies of real examples
Who can Benefit:
  • All medical device companies
  • Engineers
  • Management
  • Directors
  • VPs
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions (www.medgineering.com). David has a strong technical background, having garnered his BS and MS in Biomedical Engineering from the University of Miami with a focus on innovating around clinical needs. He is a published speaker, participating in most major medical device trade shows, including presentations at MD&M East and MD&M West, the two largest medical device conferences in the world, where he lectures on topics centering on innovative compliance practices. He also currently serves as Chief Operating Officer of ReMind Technologies, a mobile health start-up dedicated to tackling medication adherence by using smart-device based medication dispensing units and software applications.
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