Healthcare companies such as medical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for lay audience consumption around the world. From producing clinical trial lay summaries for the general public to the action-focused informational content generation aimed at the Health Care Provider (HCP) audience, the need to produce a multitude of plain language written deliverables has strained many already-stretched internal teams. How can your organization meet these challenges?
This first presentation in a three-part Deep-Dive Plain Language series from Criterion Edge examines:
• Key aspects that define plain language writing
• The regulatory and legal requirements of plain language content
• Plain language writing for multiple audiences, e.g., lay audience versus Health Care Providers (HCPs)
• Solutions to common pain points, for example, standardizing key messaging across multiple written deliverables and platforms
At the end of the presentation, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also, you can submit your questions at any point during the presentation.
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.
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.
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.
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?
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?
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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