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 Devices 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.

Benefits of 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

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

Streamline regulatory filing

Pre-market authorisation and review process templates speed approvals and collaboration across the enterprise so breakthrough innovations can reach patients more quickly.

License to Cure for Medical Device 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.

The medical device industry requires well-defined solutions for process flow, so that companies can be ready when an audit takes place. The 3DEXPERIENCE License to Cure software solution is designed to accelerate the delivery of safe, innovative and fully compliant medical devices. The software can also manage the design history file (DHF), device master record (DMR) and regulatory licenses, all in an automated fashion. It also has a module to track device complaints to the specific product version.

Download our webinar with XTalks to learn more about the License to Cure software package by TECHNIA.

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