7 Factors to Consider in Selecting a Medical Device Sterilization Contractor Medical device companies benefit by evaluating additional services, scalability, green operations For medical devices, sterility is one of the most important steps in development and production. In today’s world, sterilization and the decision on selecting a sterilization contractor may be more critical than ever. […]
Valuation Strategies for Early-Stage Medical Device Companies (Part 1) Hopes and Dreams To be an entrepreneur in the medical device field, you must have a compelling vision, a goal, a dream, a passion. But a dream without a plan is just a wish. You are probably working hard at building your company, perfecting your product […]
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.
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!
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.
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.
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.
