This webinar will examine the basic elements of the EU's QMS, ISO 13485, how to implement, areas of major concern and regulatory expectations, and how the system works together. It will examine the underlying causes for major regulated medical device industry QMS failings, as well as how ISO 13485 interfaces with the EU MDR (Medical Device Regulation).
Discussed are the EU's Notified-Bodies mandate to get tougher across the board in their expectations for the medical products industry and its compliance to the standards / regulations.
This webinar will examine the changing focus of medical device regulation, similarities and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs). We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU. Also consideered are multi-site company operations, and the supply chain; trends evident in regulatory inspections; and recent major industry failures. The result will be a company proved to be "in control" to an investigator's satisfaction; the negative role of "entropy", and proactive and reactive inspection observation avoidance techniques.
Why should you Attend: In the US we have the CGMPs, specifically 21 CFR 820, for Medical Devices. Europe has the ISO 13485;2016 standard to define their Medical Device Quality Management System. ISO 13485 now has an almost idential design control requirement. And there are many other similarities, as both QMS' strive for global harmonization. But to obtain the CE-mark, conformance to ISO 13485 together with the EU's MDD / MDR, are the requirements.
Currently there is some confusion on the definition of "risk" among many under ISO 13485. The new MDR has also resulted in some major shifts in the emphasis regulatory compliance. These shifts have a major impact on interpretation of individual compliance objectives, and measurements of success.
Recent negative publicity in the regulated industries have put pressure on the Notified Bodies to "get tougher on compliance / enforcement", adding to the importance of reevaluating ISO 13485 compliance goals, especially in light of the new EU MDR. The compliance inspections, validations, submissions / data, "better science", lifecycles, closed-loop CAPA, outsourcing / globalization and supply chain / control issues, and senior management, are all under more intense scrutiny.
Areas Covered in the Session:
Major Compliance Issues
The Tougher Regulatory Environment Shifting and New Emphasis
Changed Core Expectations
Basic ISO 13485:2016
Where does the EU's MDR Come In
What is "risk"?
Outsourcing and Globalization Issues
In-house Obstructions Before and During
Addressing the Notified-Body Certification Inspection
- Senior management in Devices and Combination Products
• Senior management in Devices and Combination Products