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
IEC 60601 TESTING: AN OVERVIEW FOR MEDICAL DEVICE DEVELOPMENT
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
5 MARKET TRENDS DRIVING ENGINEERING DESIGN DEVELOPMENT
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
HOW TO DESIGN LOW POWER DEVICES
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
SAMPLE MODELS AND BEST PRACTICES: APPLYING A RISK-BASED APPROACH TO QMS PROCESSES
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
BEST PRACTICES: MEDICAL DEVICE SOFTWARE DEVELOPED UNDER IEC 62304
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
BUILDING HOSPITAL INTUBATION BOXES FOR HEALTHCARE HEROES
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
SIMPLEXITY HELPS FIGHT COVID-19 BY BUILDING FACE SHIELDS FOR FIRST RESPONDERS
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
MD&M WEST 2020
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
TIPS FOR DESIGNING A MEDICAL DEVICE WITH A DEVELOPMENT PARTNER
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