Literature review is a vital component of the clinical evaluation procedure for medical device approval. MEDDEV 2.7/1 rev4 emphasizes the importance of quality assessment of the available evidence to achieve compliance with the new EU medical device regulations. With only a few notified bodies currently authorized to approve devices, it is important to be able to conduct the literature review in a systematic, transparent way and efficiently produce easy-to-digest data in a standardized format for the Clinical Evaluation Report (CER).
This presentation is based on lessons learned through work with dozens of organizations, across a variety of product types, that are writing CER literature reviews for regulatory submissions. The presenters will demonstrate how adopting these tools and best practices can help reduce barriers for approval by notified bodies.
In this webcast, you will gain an understanding of practical considerations to help you conduct a high-quality literature review to produce quality data output for your CERs. An example literature review protocol will be demonstrated using the DistillerSR literature review software tool and other tools for managing literature reviews will be discussed.
Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Learning Objectives
Upon the webcast's conclusion, you will be able to:
- recognize the data management challenges facing the industry to achieve compliance with EU MDR
- identify common pitfalls in the literature review process
- understand best practices for completing the literature review component of CERs to make it easier for Notified Bodies to review your submissions
Who Should Attend?
- Regulatory and medical communication professionals who are involved in the preparation of clinical evaluation reports to comply with the EU MDR
Speakers
Peter O’Blenis, ceo, 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. 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. O’Blenis holds an MBA from Queen’s University.
Derek Lord, implementation specialist, Evidence Partners
With over 10 years in the technology industry, Derek Lord applies his problem-solving skills and logical mind to help clients achieve their organizational and workflow goals. In his role on the Professional Services team at Evidence Partners, Lord has been directly involved in implementing medical device clinical evaluation report solutions and best practices for clients producing reports for device approval in the EU. He has consistently achieved a five-star rating for his work developing project templates for medical device literature review.
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.