Bogged down by countless EU-MDR guidances, standards and interpretations? Get a handle on it and stay compliant with this webinar.
FALLS CHURCH, Va., July 14, 2022 /PRNewswire-PRWeb/ -- EU-MDR's Growing Pains
Are You Current with the Latest Developments?
An FDAnews Webinar
Thursday, July 28, 2022, 11:00 a.m.–12:30 p.m. EDT
https://wcg.swoogo.com/eu-mdrs-growing-pains
Devicemakers are drowning in new EU-MDR requirements. Any new regulation, especially one of this magnitude, spurs a flurry of guidances, standards and notified body (NB) interpretations needed to stay on top of if devicemakers want to operate in the EU.
This webinar will provide attendees with the information and strategies to stay compliant in the EU now and going forward as the regulation evolves.
James Pink, senior director, medical at Element Materials Technology, will share how to stay on top of the EU-MDR requirements through a carefully designed strategy for regulatory compliance. He'll explain the constantly evolving guidances and references. And he'll disclose how the requirements will likely continue to develop, so devicemakers can stay compliant, explaining:
- The regulatory framework around the EU-MDR, including common specifications, guidances, harmonized standards and interacting EU laws
- How to develop an effective and value-added strategy for regulatory compliance, including developing tools and systems to track regulatory updates, setting equivalence requirements and managing changes to standards and medical state of the art good practices
- How to plug into those aspects of EU regulations professionals may not have known exist but are essential, including the forthcoming Artificial Intelligence Act, cybersecurity frameworks, data protection law and hazardous substance requirements
- The value, and pitfalls, of notified body, competent authority and the Medical Device Coordination Group (MDCG) guidances, including the diverging opinions on sufficient clinical evidence, substantial changes and the influence of national competent authorities
- The regulatory technologies now available to devicemakers to support their strategy for regulatory compliance, including regulatory intelligence systems, standards updates and regulatory affairs software
Compliance is possible only when devicemakers are on top of all the EU-MDR developments. Here's how to get, and stay, there.
Webinar Details
EU-MDR's Growing Pains
Are You Current with the Latest Developments?
An FDAnews Webinar
Thursday, July 28, 2022, 11:00 a.m.–12:30 p.m. EDT
https://wcg.swoogo.com/eu-mdrs-growing-pains
Tuition:
$287
Easy Ways to Order:
Online: https://wcg.swoogo.com/eu-mdrs-growing-pains
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Media Contact
Michelle Butler, FDAnews, 703-538-7665, [email protected]
SOURCE FDAnews
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