High consumer expectations for better healthcare and advances in technology that improve quality of life are creating favorable market conditions for medical device companies. But increasing regulatory scrutiny is forcing medical device manufacturers to focus more on quality and safety. The License to Cure for Medical Device industry solution experience allows companies to eliminate scattered processes and data and to “embed” regulations as an asset, optimizing quality and compliance and reducing cost and time to market.
This end-to-end solution supports all aspects of a medical device company’s quality system and regulatory compliance ISO-regulated design controls.
In addition, in an effort to address event reporting, reduce recalls and improve patient safety, manufacturers needs flexible solutions that manage the packaging and UDI code print and all quality issues including product complaints, non-conformance reporting (NCRs), audits and CAPAs, through a single, global, online system.
Преимущества License to Cure for Medical Device
Accelerate time-to-market for medical devices
Create an integrated framework for compliant innovation and
embedding quality and regulatory best practices
Improve product and process quality
High quality and 100% regulatory compliance is assured via a virtual Design History File and up-to-date Device Master Record that is linked to post-market processes
Streamline regulatory filing
Pre-market authorization and review process templates speed approvals and collaboration across the enterprise so breakthrough innovations can reach patients more quickly.
Enhance patient experience
Virtual environment for gathering customer feedback and creating
requirements that can be managed in a holistic environment with
full traceability and visibility