ON DEMAND WEBINAR
Duration: 1 hour​

The webinar profiles the critical role of standards in regulatory compliance for medical device manufacturers. It analyzes the intricate relationship between regulations and standards, emphasizing the concept of "presumption of conformity," which often allows manufacturers to use standards as evidence that their devices meet regulatory requirements. It  underscores the differences between mandatory regulations and voluntary standards, highlighting how standards are developed to ensure device safety and performance. It also discusses the global landscape of standards, including harmonized, designated, and recognized standards across different jurisdictions such as the EU, UK, and USA, illustrating the complexities and benefits of using standards for regulatory compliance, including:

• The differences and applications of harmonized, designated, and recognized standards across jurisdictions
• The need for global alignment of standards to facilitate efficient market access while ensuring device safety among often differing regulatory demands
• Upcoming changes in standards' format and content, emphasizing the need for standards to be digitally optimized to be incorporated into manufacturer management systems

SPEAKER

Lena Cordie-Bancroft
Sector Lead – Medical Devices
BSI