How the FDA's New 510(k) Guidelines Could Help or Hurt Medtech

Posted by Sundeep Karnik on January 14, 2019

Matt Singer co-wrote this blog post with Sundeep Karnik.

Recently, the FDA announced new steps to modernize its 510(k) regulatory clearance pathway. This is the first major overhaul of a process that has been in place since 1976. The FDA intends to implement three major changes:


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From Compliance to Opportunity: How to Address the EU Device Regulation Changes

Posted by Matt Scheitlin on June 27, 2018

Likely, wherever you’re based in the world, you are aware of the General Data Protection Regulation (GDPR) that went into effect in Europe on May 25. These sweeping regulation changes affect every organization that controls or processes the personal data (whether customer or staff) of personnel based in the EU. If you’re reading this blog post, then your organization has been affected by the GDPR and, hopefully, built a capability over the past few years to ensure compliance. And if you’re best in class, your company is using the GDPR requirements as an opportunity to drive your business forward.


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