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
If you are developing a medical device, knowing which testing standard will be used to evaluate the safety and effectiveness of your device is critical for obtaining FDA clearance or… Read More
As we get ready to bid 2022 farewell, we reflect on 5 market trends driving engineering design development into the future. One of the truly great pleasures of working at… Read More
Power management is an important concern when dealing with small, battery-powered devices such as sensors or wearables. The successful design of low-power devices requires a concerted team effort between the… 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
When developing software for use in the medical device industry, best practices must be followed to ensure regulatory requirements are being consistently met. As we dive into software development in… Read More
After seeing a friend at Illumina post a company-wide request for intubation boxes for area hospitals based on an open source design concept, I knew that Simplexity would be happy… Read More
We have been fortunate to have a good relationship with our clients and many of their employees. When the COVID-19 outbreak hit, people wanted to use their skills to make… Read More
General Impression We exhibited at the MD&M West Show this year and were excited by the networking connections we made. With 311,260+ Californians directly employed by Life Science companies along… Read More
So, you’ve found a niche in the ever-growing world of biotech! You’ve past the initial hurdle of closing the first round of funding and now you’re on the hook to… 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