ISO 13485:2016 Change is Coming - Is your organization ready?
Webinar - March 29th, 2018 2:00PM EDT
Join UL's Larry Mager and Karthik Sriram for the latest updates and preparation strategies around 13485:2016, and make sure your team is well prepared before the 2019 deadline.
The latest update to the definitive QMS standard for design and manufacture of medical devices, ISO 13485, was published on March 1, 2016. This new version incorporates feedback and input from experts around the world to improve and update the standard with new European requirements and other international regulatory changes, implemented since its previous revision in 2003.
The ISO 13485: 2016 Standard allows medical device organizations to obtain external recognition of conformity of the quality management system to accepted requirements via certification. This important standard was recently revised to achieve the following objectives:
- Improve the clarity of the requirements
- Increase the confidence that the requirements are consistent with cGMPs or current Quality System regulatory requirements/objectives
- Increase harmonization of QMS regulatory requirements
- Increase medical device manufacturers’ ability to meet customer/stakeholder requirements
- Improve the capability of medical device manufacturers to address product safety and effectiveness
Please join us for this informative webinar so you can stay up-to-date on:
- What’s new in the standard?
- An overview of significant changes/updates that are in play with the new standard
- MythBusters: When do companies have to be ready by?
- What are important areas to focus on to get your organization for your re-certification?
- Risk management – how it is integrated with QMS?
- Supplier Risk Management
- Risk management within key quality processes
- Patient centricity as a key philosophy behind risk management
Timelines and key milestones
PURE Learning Blog: “The ISO 13485:2016 Medical Device Regulation Deadline Nears” (Karthik Sriram)