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