The United States-Mexico-Canada Agreement (USMCA) — if ratified by the end of 2019 — will replace the North American Free Trade Agreement (NAFTA) in 2...
What the Two-Year EUDAMED Delay Means for Medical Device Companies
The European Commission recently announced it would delay the launch of the European Database on Medical Devices (EUDAMED) for two years. This announc...
A Compliance Manager’s Wish List for the Holidays
A year in the life of a compliance manager is filled with mountains of data, cumbersome spreadsheets and constant changes to regulations. It’s enough ...
REACH Enforcement Project Reveals Failings in Company Communications on SVHCs
On November 6, 2019, the European Chemicals Agency (ECHA) released a report outlining the results of an enforcement pilot project conducted between Oc...
Ongoing Story: Update on Notified Bodies & Certifications Under the EU MDR
The European Union (EU) Medical Device Regulation (MDR) comes into force on May 16, 2020, and compliance officers are encountering challenges as the d...
Four Facts to Know About Technical Documentation
Demonstrating compliance with restricted substance legislation like the Restriction of Hazardous Substances (RoHS) Directive and the Registration, Eva...
Australia Issues Guidance on Modern Slavery Act
The Australian Department of Home Affairs recently released a companion document to the Australian Modern Slavery Act of 2018 (MSA). The document, tit...
The Scope of the EU Medical Device Regulation
The European Union (EU) Medical Device Regulation (MDR) is due to take full effect in May 2020, and its new scope includes a large number of products ...
Leveraging Data Automation & the Media to Monitor Vendor Practices
If you were hiring an employee, would you simply accept the best candidate on paper, or would you conduct interviews and investigate them online? In t...
What the Brexit Extension Means for Businesses
The Extension On October 28, 2019, the UK formally asked for and accepted a three-month extension to the European Union (EU) departure date and is now...