April 13, 2021

[FEATURED] EU Regulations At A Click: Top 10 Most Useful MDR/IVDR Webpages

The EU Medical Device Regulation will have impacts in countries beyond the EU27, a fact that is keeping MedTech Europe’s international team very busy.

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March 30, 2021

[FEATURED] Why The Humble Swab Could Be A Seriously Disruptive Element In The MDR And IVDR

Health care is about to suffer a major setback and some devices and IVDs are going to have to be held back from the market if the regulatory status of the humble swab is not sufficiently recognized and urgently addressed.

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March 23, 2021

[FEATURED] EU MDR Notified Body Designations Could Soar By A Third By End Of 2021

Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having to find ways of limiting the damage that newly erected barriers will cause after the MDR comes into force.

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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. 

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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March 2, 2021

[FEATURED] Commission Issues New Guidance On Registering And Identifying Legacy Devices In Eudamed

The process for registering legacy devices is like that for registering devices in conformity with the MDR. But there are differences and manufacturers also need to understand how deadlines impact them.

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