February 22, 2023

[FREE WEBINAR] Plain Language Communication in Healthcare Part 1 Webinar

Click here to watch the recording of this webinar.

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? 

Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written communication can help ensure key health information and clinical research findings are understandable and accessible to all.  ​

Content is the user experience.  Make your words count.

Key Takeaways

  • Key aspects that define plain language writing​
  • Plain language content writing for multiple audiences​
  • What is readability and suitability?​
  • The regulatory and legal requirements of plain language content​
  • Project planning for publication of Plain Language Summaries

Who are the Panelists?

Laurie W. Mitchell, President, Criterion Edge

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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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February 9, 2023

[FREE WEBINAR] New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference

Click here to watch the recording of this webinar.

The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe.  IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR. 

In October 2022, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was honored to be an invited speaker and join with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.   

Attendees to this Criterion Edge webinar will benefit from key insider insights gleaned from this meeting, as Sarah will be share and discuss the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track.  Most companies are in the early stages of planning for IVDR, so the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers. 

Key Takeaways

  • What are the major changes from IVDD to IVDR?
  • How does IVDR define “Clinical Evidence,” and where can you find it?
  • What are the Notified Body’s expectations (and advice)?

Who Should Watch?

Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of performance evaluation reports for IVDR submissions.  

Who are the Panelists?

Dr. Sarah Chavez, Director, IVD & Scientific Writing Services

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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November 23, 2021

[FEATURED] MRA Or Not, Swiss Medtech Industry Urges Maximum Convergence With EU MDR

Swiss domestic medtech manufacturers reluctantly accept Switzerland’s new status as a third country to the EU, but the Swiss industry is anxious that new national regulations do not impose higher hurdles than the EU MDR. At present, there is a risk of that happening.

Swiss medtech manufacturers appear to have taken a pragmatic view of the country’s newfound status as a third country to the EU, in the months since the EU Medical Device Regulation took effect. In the absence of the mutual recognition agreement (MRA) with the EU, the MDR does not apply directly in Switzerland, as the medical device directives did, so Switzerland enacted its own national Medical Device Ordinance (MedDO/MepV).

The revised Swiss medical device legislation was put in place to maintain Switzerland’s orientation towards both the MDR and the future IVD Regulation, regarding product quality, safety and efficacy. At some point in the future, a Swiss referendum might lead to a situation where mutual recognition and free market access are once again in place for both parties.

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November 16, 2021

[FEATURED] Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap

The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.

The urgency of having the necessary structures in place, including notified bodies, so that manufacturers can comply with the IVD Regulation, continues to be emphasized by all stakeholders in the EU IVD sector.

Accompanying this is a general sense that there has been a lack of transparency about when additional designations will be made, which hinders companies’ preparations.

The latest figures from the European Commission show that progress is being made, but not as quickly as the sector would like.

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October 5, 2021

[FEATURED] GMed Designated Under EU IVD Regulation

In the EU, there are now six EU notified bodies designated under the IVD Regulation.

French notified body, GMed, has been designated under the IVD Regulation for a comprehensive scope of products.

This brings the total number of IVDR notified bodies to six. The latest designation comes with just nine months to go until the regulation fully applies from 26 May 2022. 

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