Skip to main content

Author:

Medical Device

An Overview of European Unique Device Identification System

Medical Device

The EU Medical Device Regulations (EU 2017/745 and EU 2017/746) introduce a comprehensive Unique Device Identification (UDI) system designed to uniquely and consistently identify medical devices throughout...

Continue reading

Medical Device

Why is Medical Technology Getting Shrouded by the Fear of Cybersecurity Issues?

Medical Device

Cybersecurity threats top the list when it comes to imminent dangers surrounding the healthcare industry. Every technologically driven device has a high chance of security breach and the main reason...

Continue reading

Medical Device

USA: FDA Drafts Guidance on Patient Engagement in Device Trials

Medical Device

The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers should engage patients when designing medical devices. This Draft Guidance is Intended...

Continue reading

Biopharma

Regulatory Intelligence (RI) Unbolts all your Regulatory Challenges

Biopharma

In today’s globalized life sciences environment, drug development has become more complex than ever. Regulatory Intelligence (RI)—a relatively new but essential function within global Regulatory Affairs...

Continue reading

Standards

Luxembourg and The Netherlands benefit from the EU-US Mutual Recognition Agreement for Inspections

Standards

Luxembourg and the Netherlands have now been incorporated into the Mutual Recognition Agreement (MRA) between the European Union (EU) and the U.S. Food and Drug Administration (FDA). Through this agreement,...

Continue reading