March 5, 2018

[FEATURED] EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis?

“Since the EU’s new Medical Device and IVD Regulations took effect in May 2017, progress toward implementation has been painfully slow. So, what is needed in 2018 to ensure the MDR and IVDR are viable?”

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December 20, 2017

EU MDR and Clinical Evidence: What You Need to Know

“One of the key objectives of the new EU MDR is to ensure a high level of health and safety protection for EU citizens. Making clinical investigation and evaluation requirements more stringent is aimed at improving health and safety through transparency and traceability.”

 

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November 13, 2017

Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline

“European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues.”

 

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September 28, 2017

Learn From Past Mistakes: Preparing For MDSAP And International Commercialization

Learn about some of the most common European regulatory compliance mistakes and how to avoid them.

 

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RAPS Regulatory Convergence 2019

September 21-24, 2019

Philadelphia, PA

Register today to examine regulatory challenges and solutions with top industry professionals.

Book a consultation with us! President Laurie Mitchell and CEO Lalitha Jonnavithula will be taking meetings at booth #349. 

Stop by for exclusive assets, tips, or to discuss regulatory or medical writing projects. And while you’re there… sign up for the chance to win a FREE Amazon Echo!