Boulder iQ selects first firm for medical-device accelerator
Boulder Daily Camera, BizWest – March 10, 2021
Stressed Testing: Challenges with Medical Device Testing
MPO Magazine – March, 2021
Boulder iQ Selects CardioScout for Medical Device Accelerator Program
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), which focused on the pre-approval stage of medical device manufacturing.
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 be further from the truth!
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, have electronics, or sensitive to high amounts of humidity, the gas can penetrate through almost all materials other than metal making it very effective.
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 out to be a significant year of growth for us in the services we are able to offer our clients.
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 13485 and similar oversight regulations have significantly improved the quality of medical device designs.