March 18, 2021

[FREE WEBINAR] Leveraging the MDR experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes

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.

Who should watch?

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. 

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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.

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September 29, 2020

[FEATURED] EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures

Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.

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April 11, 2019

[FEATURED] IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU’s IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

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