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:
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.