Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management

Release Date
September 04, 2019 10:00 AM CT U.S.

View the recorded webinar here!

Updates to ISO 14971: “Application of Risk Management to Medical Devices,” and its companion Technical Report ISO TR 24971: “Guidance on the Application of ISO 14971,” are soon to be released.

Within the ISO 14971 updates, eight major changes are being made to the standard to address risk management of medical devices from inception to post-production. These modifications will impact both the risk management of new product development, as well as the risk management of existing products files.

ISO TR 24971 has also undergone a major revision; as such, the Technical Report provides extensive information on how manufacturers are to implement the newest version of ISO 14971 and also presents examples of risk management tools for device Sponsors.

The information in the recent ISO updates also align well with the EU’s Medical Device Regulation (MDR) 2017/745, particularly in the area of Post-Market Surveillance.

This webinar will discuss the major changes and updates and provide information as to why they are being made. We will also highlight the potential impact on new and existing risk management files, and how the new standard aligns with MDR.

Attendees who attend this webinar can expect to:

Time will also be allotted for Q&A.

View the recorded webinar here!

About the Presenters:

 

Linda Mummah-Schendel

Principal Quality Consultant, NAMSA

Linda Mummah-Schendel has over 30 years of regulatory experience in the medical device industry. She has developed, implemented and trained on new and re-engineered Quality Systems, including projects related to continuous improvement, product non-conformance, CAPA systems and root cause analyses. She has led multiple project management and development activities for a wide variety of medical devices and combination drug/devices, including IVD and biopharmaceutical products. An expert in GMP regulation and ISO 13485 Quality System requirements, Ms. Mummah-Schendel also has extensive knowledge and experience surrounding IDE and PMA submissions.

Rich Granquist

Senior Quality System Consultant, NAMSA

Rich Granquist joined NAMSA in 2015 and has been in the medical device industry for 14 years in Global Quality Assurance and EU Regulatory Affairs. He has a certification in Biomedical Auditing and his special areas of experience includes Risk Management, Complaint and CAPA investigation, Sterilization Validation, Preclinical Testing, and Technical File Management. Recently he has focused on awareness of the impact of the European MDR on Quality Systems, Product Development and Risk Management.