July 21, 2021

[FREE WHITE PAPER] State of the Art: Establishing a Solid Foundation For Your PERs to Encourage IVDR Readiness

Overview

This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR).

Manufacturers are expected to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged to reflect the most current best-practice science. To establish that your IVD is SOA, you must be able to show how it fits into the entire scientific landscape and explain the circumstances and diagnostic scenarios by which the IVD can be considered SOA.

Solution

Knowing what the Notified Body expects to see will help you avoid …

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July 12, 2021

[FREE WHITE PAPER] Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization

Overview

This white paper is a companion piece to our popular webinar where we share our insights on using the Systematic Literature Review (SLR) to Empower Data-Driven Decisions in your Organization.

Every day, pharma and medical device companies need data from SLRs to inform, direct, and help drive their internal processes and decisions that move their companies forward. Of course, clinical literature is also required for compliance with global regulatory requirements. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.

Solution

Adopting a transparent, reproducible, and robust process for SLRs is essential to …

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July 9, 2021

[FREE WEBINAR] Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements.

Click here to watch the recording of this webinar.

There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures. But what of organizational change management readiness? How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently?

Watch the recorded webinar for a behind the scenes look at how one company is managing change within their organization. Dr. Imelda Omana-Zapata, BD Senior Manager Clinical Projects, will provide an overview of how she is planning and coordinating change within her organization to meet upcoming EU IVDR regulatory requirements. Laurie Mitchell, Founder and President of Criterion Edge, will discuss the critical technology and expertise required to meet more rigorous scientific validated submissions to notify bodies.

Key Takeaways:

  • Key steps involved in helping medical affairs transition to a more rigorous regulatory environments.
  • How to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
  • Critical systematic literature review technology and experience required to ensure CER and PER submissions are audit-ready and compliant.

Who Should Watch:

  • Medical Device & Diagnostics Professionals (from small-medium sized to large enterprises)

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge
Dr. Imelda Omana-Zapata, Senior Manager, Clinical Projects | BD

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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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July 6, 2021

[FREE WHITE PAPER] 5 Key Strategies for Effective Corporate Scientific Communication

Overview

This white paper is a companion piece to our popular webinar where we share some of the best approaches we have discovered for Corporate Scientific Communication Strategies.

A well-developed and well-executed Scientific Communication Plan can have positive impact on market awareness and company goals. This requires top-level, strategic perspective, and project level review and discussion to effectively frame the message. Multi-disciplinary planning, goal-oriented strategies, and project level-checks are just some of the important aspects of data-driven clinical and scientific communications that maximize market impact. But, who among your team are the right people to be assigned the task of preparing, supporting, and pushing along a written project to completion?

Solution

The best advice we can give is taken from …

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June 17, 2021

[FREE WEBINAR] Driving Innovation to Success in the Market: Strategic Considerations

Get a copy of the slides from this webinar or click to watch the recording.

In this live 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.

Who are the panelists?

Laurie Mitchell, President | Criterion Edge
Caroline Byrd,  VP of Regulatory, Quality, and Clinical | Nextern 
Dr. Krishna Sudhir, Divisional VP, Medical Affairs and Product Performance | Abbott Vascular 
Sidney Collin, Cofounder and CEO | De Oro Devices

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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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