License to Cure

mai-licence-to-cure

Transforms traditional disconnected business projects into a framework which accelerates the delivery of innovative, safe, and fully compliant medical devices. This end-to-end solution supports all aspects of a medical device company’s quality system and regulatory compliance ISO-regulated design controls.

A full framework which accelerates the delivery of innovative, safe and fully compliant medical devices.

Challenges

  • Increasing product complexity in a race for innovation
  • Legacy paper-based systems, or siloed electronic documents
  • Painful traceability assessment and consequently audit risk
  • Difficult assessment of complete change impact
  • Balancing innovation and regulatory requirements
  • Globalization / Pricing Demands / Developing products for emerging markets
  • Accelerating new product introductions
  • Siloed Organizations (R&D, Quality, Marketing, Regulatory, Mfg., Supply Chain)
  • Maximizing IP capitalization & reuse
  • Decentralization of R&D & Manufacturing
  • Increasing margins to accommodate outcomes based health economics
  • Increased Regulatory Scrutiny

Key Features

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.

License for Requirement Change

  • Requirements Management with Complete Traceability

License for DHF Change

  • DHF - Design History File
  • Program Management,
  • Deliverables-based Project Planning

License for DMR Change

  • DMR – Device Master Record
  • Eng. / Mfg. BOM & DMR Management
  • Quality Based Document Control

License for Green

  • Material Compliance Management
  • Material Compliance Declaration
  • Material Compliance Analysis

License for Regulatory

  • Global Market Registration
  • Device Identification Records (DI-GUDID)
  • Adverse Event (eMDR)
  • Deliverables-based Project Planning

License for Quality

  • Complaints & Non-Conformance Reports (NCR)
  • CAPA & Audits

License for Document Control

  • Quality Based Document Control (Training & Implementation)
  • Change Management
  • Classification & Component Management & Reuse

Benefits

  • Speed up the design and development process (*)
  • Reduce cost of design errors
  • Reduce time to answer to auditors.