In the first installment of this webinar series, Criterion Edge presents strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. This practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.
In the second installment, we continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, examining the clinical data sources, equivalence, and risk/benefit analysis profile sections of the CER.
Finally, in the third presentation we share with you some of the biggest issues we have discovered when starting an MDR CER project based on our experiences with clients both large and small, and we also reveal some of the most successful strategies in addressing these issues, up-front and early.
Click here to watch our free webinar series to develop MDR-ready CERs.
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Get a copy of the slides from this webinar or click to watch the recording.
In this presentation, we provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
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Criterion Edge provides free scoping of your PERs. Is it time to get them reviewed? Book your free consult.
Get a copy of the slides from this webinar or click to watch the recording.
With the implementation of IVDR requirements and 2022 deadline approaching, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
Key Takeaways:
•The importance of scoping your PER project in advance
•The critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete
•How to identify those hidden gaps in resources and information and the steps to take to mitigate them
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Get a copy of the slides from this webinar or click to watch the recording.
Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? In this presentation, President Laurie Mitchell is joined by Caroline Byrd, the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Watch this discussion of their experiences supporting clients through MDR and IVDR requirements.
All regulatory, clinical, and scientific professionals who are tasked with the development, writing, review or approval of scientific manuscripts, reports, presentations, and other forms of communications in the medical device, pharmaceutical, and diagnostics space.
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Get a copy of the slides from this webinar or click to watch the recording.
A comprehensive scientific communications program is a critical tool for medical device, in vitro diagnostic and pharma companies to raise market awareness for their products. Done well, effective “real-world” communication can position your company as a key scientific leader in its field and drive market adoption and sales. However, ineffective or poorly executed scientific communications can result in lost opportunities to make an early, meaningful and even a positive impact on the market.
In this practical presentation, President Laurie Mitchell: 1) discusses how an effective scientific communication plan is an important marketing tool for an organization, and 2) presents five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Watch to learn how this applies to your organization and how to implement these strategies into your current processes.
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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