After the UK formally left the European Union (EU) on January 31, 2020, a number of questions remained regarding the impact on businesses selling prod...
Proposed Update to EU MDR Deadline
The COVID-19 (coronavirus) outbreak has put a halt to many aspects of everyday life around the world. As infection rates and the death toll mount, peo...
EU MDR: What to Do if Your Company Is Unable to Comply by the Deadline
Will your products be compliant with the European Union (EU) Medical Device Regulation (MDR) when it takes full effect on May 26, 2020? Since the intr...
Ask the Experts: Responsible Mineral Reporting & Tungsten Welding
Our regulatory subject matter experts help a range of stakeholders solve compelling regulatory challenges associated with supply chain data management...
EU MDR Three Months Out: A Checklist
For medical device companies in the European Union (EU), the May 26, 2020, application date for the EU Medical Device Regulation (MDR) looms large on ...
Ask the Experts: The Difference Between REACH Restricted Substances & Candidate Lists
Our regulatory subject matter experts help a range of stakeholders solve compelling regulatory challenges associated with supply chain data management...
Ask the Experts: January 10 Edition
Our regulatory subject matter experts help a range of stakeholders solve compelling regulatory challenges associated with supply chain data management...
Top Regulatory Changes to Be Aware of in 2020
Regulatory pressure is increasing. Companies that fell short of expectations in the last few years have seen their brands take reputational hits, expe...
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...
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...