Quality

Choose a Key Feature of Advant’s Quality Management System

Lean Six Sigma Product & Process Development

Advant Medical nurture a Lean philosophy providing innovative and world class manufacturing techniques by consistently incorporating lean principles to maximise efficiencies, eliminate waste, streamline business processes and effectively increase speed to market for our customers.
We are committed to delivering innovative solutions that deliver real advantages to our customers.

Supporting our Lean philosophy is a team who are certified and highly experienced in:

  • Lean Business Practices (LBP)
  • New Product Introduction (NPI)
  • Six Sigma Problem-Solving and Process Improvement

Risk-Based Validation – ISO 14971

At Advant Medical, all our validations are performed in accordance with ISO 14971: 2004 guidance.
This risk-based approach ultimately safe-guards the patient by producing components and devices that are safe, effective and meet our customers’ requirements.

Technical File and Design Dossier Submission Support

Advant Medical is experienced in Technical File and Design Dossier Compilation. We can support all aspects of a customer’s submission, assisting and providing guidance in areas such as:

  • Medical Device Regulatory Requirements (ISO, MDD, 21CFR, USP, etc.)
  • Component Material Selection
  • Test Method Development
  • Risk Analysis Report (DFMEA, PFMEA, etc)(ISO 14971; GHTF Guidelines)
  • Biocompatibility Assessment (ISO 10993, USP Class VI)
  • Sterilization Validation Planning (ISO 11137)
  • Packaging Testing (ISO 11607)

Integrated Quality System and Change Control

Advant Medical has developed a custom-built software solution to effectively control quality records and change control.
It is an integrated system that inclusively manages:

  • Purchasing
  • Documentation (SOPs, Forms, etc)
  • Non-Conformance Reporting
  • CAPA
  • Customer Information

This system is currently in the process of being validated to 21CFR Part 11 to comply with FDA requirements on electronic records and electronic signatures.

ISO 13485: 2012 Accredited Quality System

Advant Medical operates a Quality Management System which is accredited to ISO 13485: 2012 standard.

Download and Print ISO Certificate Here

Effective Supply Chain Management

Advant Medical provides a comprehensive supply chain management solution from initial planning to final distribution. We monitor and approve all our suppliers in accordance with the requirements of ISO 13485: 2012.
Our approach to supply chain management ensures that all critical suppliers maintain a quality management system which supplies components which are appropriately qualified, and which therefore result in medical devices which are safe, effective and meet customer requirements.

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