Press Release (ePRNews.com) - TORONTO - Nov 28, 2018 - The term “state of the art” appears approximately 39 times in MEDDEV 2.7/1 rev. 4 (compared to just four times in the previous version of the regulations).
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev. 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management and equivalence.
Approaching the May 2020 deadline for the new EU MDR, this live webinar scheduled for Tuesday, Dec. 11, 2018, at 12 p.m. EST will discuss the best practices and tools that can be adopted right now to produce fully compliant state of the art literature reviews.
Join featured speakers Peter O’Blenis, President of Evidence Partners, and Laurie Mitchell, President of Criterion Edge, to learn:
- Key components of an effective state of the art description – what the notified bodies expect to see
- Common points of failure in state of the art literature reviews
- Sound methods and expert tips for completing an effective literature search
- Best practices to efficiently produce and maintain a fully compliant and audit-ready clinical background/state of the art description using DistillerSR
For more information about this complimentary webinar, visit State of the Art Literature Review for EU MDR Compliance: How To Get It Right.
ABOUT EVIDENCE PARTNERS
Evidence Partners is the creator of DistillerSR, the world’s most widely used literature review software. DistillerSR helps regulatory groups manage fully compliant and audit-ready literature reviews quickly and easily.
ABOUT CRITERION EDGE
Criterion Edge is a regulatory writing company that provides outsourced writing services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing best practices, honed over decades, produces superior deliverables and provides budget, resource and timeline flexibility for regulatory managers. Criterion Edge empowers companies to deliver superior health care solutions. To learn more about how Criterion Edge can help companies achieve regulatory goals, see criterionedge.com or contact the company at email@example.com.
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks, visit http://xtalks.com.
For information about hosting a webinar, visit http://xtalks.com/why-host-a-webinar/.
Sarah Hand Source :
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