Cook Biomedical Pty Ltd

Active implantable medical device design and process development
• Lean & Six-Sigma methodologies
• Design: CAD, engineering drawings, geometric dimensioning and tolerancing (GD&T) to ANSI Y14.5, tolerance stack up and analysis, design for manufacturing (DFM), requirements management
• Process: Development and characterization, machine programming, equipment qualification (IQ) and maintenance, process validation (OQ/PQ), software validation, statistical process control (SPC), supplier component/tooling qualification, procedures and work instructions, process records and travelers, training
• Testing: Test method validation (TMV and Gage R&R), test method development, co-ordinate measuring machines (CMM) (Mitutoyo MCosmos, Hexagon PCDMIS, Zeiss Calypso), vision measurement (Smartscope, MicroVu), surface profilometry (both stylus and non-contact), custom automated test systems
• Corrective and Preventative Action (CAPA)
• Risk Analysis and Root Cause Analysis
• Non-conformance reports and investigations
• Failure Mode and Effects Analysis (FMEA)
• Design of experiments (DoE), predictive capability, Monte Carlo analysis
• Design controls and design transfer
• ISO13485, FDA CFR Title 21 Part 820 & Part 11

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