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 putting medical device manufacturers under the gun on total quality and safety. License to Cure for Medical Device solution 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.
- Conquering complexity focusing on regulatory compliance
- Embedding regulatory compliance as an asset
- Balancing innovation in product development with Quality & Safety