Managing regulatory documents and standards in today's medical device industry has become increasingly complex. Organizations struggle with handling large, intricate regulatory documents, understanding the relationships between standards, and executing thorough impact and gap analyses when changes to content of regulatory documents occur. The burden on subject matter experts and departments responsible for maintaining compliance throughout these changes continues to grow, demanding smarter, more efficient approaches.
What You'll Learn
This webinar demonstrates how organizations can leverage SMART standards technology to streamline their regulatory requirements management, from importing requirements directly from external databases to implementing them seamlessly into development projects.
Key topics include:
- Direct import and implementation of regulatory requirements from external databases into development workflows
- Digital tools for handling content changes across regulatory documents and standards to streamline impact and gap analysis
- Managing complex relationships between standards
- Ensuring traceability and compliance throughout product development
