March 1, 2022

[FEATURED] Pharma, Device Groups Oppose FDA’s Planned Drug to Device Transition

Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision.

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February 17, 2022

Federal Court Rules that Some Imaging Agents Must be Classified as Medical Devices, Not Drugs

In case you missed it: in Genus Med. Techs., LLC v. FDA, 2021, Federal court rules that some imaging agents must be classified as medical devices, not drugs.

Recently, the FDA lost its bid in federal court to retain the discretion to classify some imaging agents as drugs, even when they meet the definition of a device. This ruling has provoked continuing objections from both pharma and medical device industry players, as companies would be faced with the challenges to switch from drug good manufacturing practices (GMPs) to the quality systems regulations that apply to medical devices.

What do you think? Join the conversation online.


Criterion Edge Can Support Your Transition to Compliance

Reach out to Criterion Edge for support to get your technical documents of existing devices ready for MDR transition. Or get your new devices MDR compliant. We have expert medical writers to support your organizations in developing the necessary documents to ensure a smooth transition and meet these fast-moving deadlines. Get a free consultation today.

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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 …

Download the rest of this white paper here.


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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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

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?

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February 19, 2021

[FREE WEBINAR] Effective Corporate Scientific Communication: Strategies to Support your Corporate Narrative and Maximize the Real-World Impact of your Data

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?

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Named the #1 Regulatory Services Company 2022 by Life Sciences Review

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