Our Blog
The Boulder IQ blog provides articles and whitepapers that are related to diagnostics and medical devices. We cover topics from sterilization, regulatory, product design and development, manufacturing, methodology, and more. We are excited to share our thoughts with you and hope you find them helpful.
The EU Medical Device Regulation: Post Market Surveillance
The EU Medical Devices Regulation (MDR) goes into effect on May 21st. The MDR takes more of a life-cycle approach than the Medical Devices Directive (MDD),…
Avoiding Failure to Launch
A venture capitalist once said that in his experience no really good idea failed due to lack of resources. In my over 25 years of experience, nothing could…
Quick Turnaround Ethylene Oxide Sterilization
Ethylene Oxide (EO) sterilization is a method routinely used for product that needs to be sterile. EO is particularly great for products that are plastic,…
From the Desk of Founder Jim Kasic
2020 was quite a year! Everyone was impacted by the pandemic and associated economic challenges. At Boulder iQ we were affected as well, but 2020 turned…
Think Fast! Challenging the Phase-Gate Paradigm to Improve Time to Market
Medical device development is a regulated activity, and rightfully so. The provisions of the FDA Quality System Regulation, international standard ISO…
