State of the Art Literature Review for EU MDR Compliance: How To Get It Right

Medical Device Clinical Trials, Medical Device Manufacturing & Supply Chain, Medical Device Safety and Regulation,
  • Tuesday, December 11, 2018

Did you know that 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.

As we approach the May 2020 deadline for the new EU MDR, this webinar will discuss the best practices and tools that can be adopted right now to produce fully compliant state of the art literature reviews.

Join this webinar 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

Speakers

Peter O’Blenis, President, Evidence Partners

Peter O’Blenis co-founded Evidence Partners in 2008 to develop leading edge technology that helps researchers deliver higher quality evidence, faster. The company’s core product, DistillerSR, is now the world’s most widely used literature review software.

As a pioneer in literature review automation, Peter’s passion for the subject has made him a sought-after speaker and resource. He has worked with over 250 research groups around the globe since 2001 and has published extensively on best practices and methodologies for using technology to improve the review process.

Peter previously held senior management roles with Oracle, WebGain, Mitel, and Flick Software. He holds an MBA from Queen’s University and a Bachelor of Computer Science from Carleton University.

Message Presenter

Laurie Mitchell, President, Criterion Edge

Laurie Mitchell is the Founder and President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years’ experience in clinical research, primarily in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety Consultant for Abbott Vascular for almost a decade.

Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise across many therapeutic areas. She holds a Master of Nursing as a Cardiopulmonary Clinical Nurse Specialist from the University of California, Los Angeles.

Message Presenter

Who Should Attend?

  • Regulatory Affairs
  • Quality Assurance
  • Clinical Evaluation/Clinical Affairs
  • Medical Writer

What You Will Learn

Join this webinar 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

Xtalks Partners

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.

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 you achieve your regulatory goals, see criterionedge.com, or contact the company at info@criterionedge.com.

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