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...
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 ...
Ask the Experts November 8 Edition
Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain d...
Understanding Section 10.4.1 of the EU MDR
After a three-year transition period, the European Union (EU) Medical Device Regulation (MDR) 2017/745 is set to take full effect on May 26, 2020, rep...
Final SCHEER Committee Phthalate Benefit-Risk Assessment Guidelines Published
After a lengthy public consultation period, the European Commission’s long-awaited Scientific Committee on Health, Environmental and Emerging Risks (S...
Ask the Experts: August 16 Edition
Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain d...