Having been associated with medical device development directly and tangentially for many years, I have witnessed and used a few things that make a difference. I would like to share… Read More
The ISO 13485:2016 standard for medical devices requires that a“risk-based approach” be used in the control of appropriate process needed for the Quality Management System (QMS). This informative blog written… Read More
The American Association for Clinical Chemistry (AACC) hosted its annual scientific meeting from July 29 to August 2, 2018. An estimated 20,000 attendees walked through the doors of the McCormick Place Convention… Read More
Human beings have been practicing medicine in one form or another since we first began using tools. Until very recently, however, all approaches to medicine had one thing in common… Read More
The San Diego Biotech Consortium is a regional partnership of service companies dedicated to promoting best practices in product development for the Biotech industry. The Consortium offers leaders of biotech… Read More
Software: Design Complete
Hardware: Pre-production units for design verification
MFG. Readiness: CM schedule and budget, Unit build tracking
Software: Full feature implementationHardware: Prototype 2 units with production-representative materials and processes
Quality: Build Quality PlanSoftware: Core functionality implementationHardware: Prototype 1 units with rapid prototyped components
Quality: Critical manufacturing process identificationSoftware: Architecture design: block, sequence and state diagramsHardware: Major Component definition & Proof of Concept subsystems build
Quality: Design for Manufacturing tradeoffs evaluation