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.
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.
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.
- Upon the webcast's
conclusion, you will be able to:
- recognize the data
management challenges facing the industry to achieve compliance with EU
common pitfalls in the literature review process
best practices for completing the literature review component of CERs to
make it easier for Notified Bodies to review your submissions
- Regulatory and medical communication
professionals who are involved in the preparation of clinical evaluation
reports to comply with the EU MDR
Peter O’Blenis, ceo, Evidence Partners
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.
Duane Leitch, director of operations and project management, Evidence
Duane joined the Evidence Partners team in 2016 and has leveraged his
extensive technical and business background to oversee a wide range of
strategic initiatives and innovative programs to enhance the client’s
experience. In his role as head of the Professional Services Team, Leitch has
been involved in delivering eighteen medical device clinical evaluation report
solutions to 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.
includes access to handouts, presentation slides and the on-demand recording
for one year.