Free live webinar: november 21st, 1:00 pm et / 10:00 am pt

An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019

Watch the webinar

 

Today's medical device regulatory environment is changing faster than ever.

The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.

The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.

These may include simple reference changes in procedures, or revision to production and post-production processes that may be required.

Greenlight Guru has partnered with a special guest to cover this topic and help you stay ahead of these changes.

This free 60 minute webinar will be presented by Edwin Bills, international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard. Mr. Bills has all of the exclusive, insider knowledge on these changes that he's agreed to share with us during this live event.

Specifically this webinar will cover: 

  • A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.
  • Reasons for the changes to the latest version
  • How to prepare for the coming changes in the standard
  • What you need to know about updates to the reorganization of informative annexes
  • Confusion in the EU and future of harmonized risk management standard
  • Q&A Session

Who should attend?

  • Medical Device Industry Executives
  • Quality Professionals and Management
  • Regulatory Professionals and Management
  • Clinical Affairs Professionals and Management
  • R&D Engineers and Management

 

Presenter

 ed_bills

Edwin Bills
Consultant

Moderator

 jon-speer-round

Jon Speer
Founder, VP of QA/RA
Greenlight Guru

 
 
lockup-green-1
 
About greenlight guru

Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our homepage to learn more.

 

 

 

 
 
ABOUT Edwin bills

During his career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions for major medical device companies, including a period as Corporate Director of Risk Management. He has over 36 years’ experience in the field of quality and regulatory affairs, including time as Director of Quality and Regulatory concurrently for four US sites. Currently he consults and provides training in the area of medical device quality, regulatory and risk management. With Stan Mastrangelo, he co-authored Lifecycle Risk Management for Healthcare Products: From Research Through Disposal published by PDA.

Mr. Bills was also a member of the adjunct faculty serving Virginia Tech’s graduate on-line degree program in Health Products Risk Management. ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is a Regulatory Affairs Certified by the Regulatory Affairs Professionals Society.

Additionally, Mr. Bills serves in international standards work, assisted in completing the revision of the third edition of ISO 14971 risk management standard as an international member of the technical committee. He also serves on the US national committee for the medical devices quality system standard, ISO 13485 and the AAMI technical committee CP, developing a combination products risk management guidance.
.

 

 

FEATURED IN