Accurate management of regulatory information including regulatory strategy and planning, product submission packages, correspondences, certificates, UDI and registrations can be challenging for medical device companies. The result is inhibited revenue, compliance violations and patient safety concerns. Organizations, especially as they grow, struggle for adequate regulatory resources, have conflicting data sources and disconnect from other functions in the value chain.
In this session we explore the power of implementing RIMS as part of a digital thread, avoiding many of the classic issues found with the classic "point system approach".
Learning Objectives:
Discover how connecting Regulatory Information to Product Data and Systems alleviates pain points of medical device companies
Learn how having a single source of information for technical documentation and data with change control helps medical device companies go to market faster and improve efficiency in their submission process
- See how centrally managed product registration with connected data, people and processes improves compliance with the regulatory authorities and reduces revenue losses
