October 30, 2017

10 Implications to Medical Device Companies caused by the MedDev v4 Requirements

Medical device industry standards are in constant flux. Standards are frequently updated to meet conformity requirements. So what are the clinical requirements that you need to be aware of to stay compliant? (more…)

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May 12, 2017

New MEDDEV Guidelines: What You Need to Know

In July 2016, revision 4 of the MEDDEV 2.7/1 guidelines was released to much anticipation within the medical device community. The document has been expanded and now contains expanded details on requirements that effect almost every aspect of the clinical evaluation of medical devices with CE-mark. So what do you need to know to make sure your organization is in compliance? (more…)

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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!