The New EU: IVDR (In Vitro Diagnostic Medical Devices Regulation) and Economic Operators Mike Andrews, Ph.D., Vice President, Regulatory and Quality, Boulder iQ Introduction The EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will replace the EU In Vitro Diagnostic Medical Devices Directive 98/79 (IVDD). Compliance with the IVDR is required no later than May […]
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. […]
Colorado BioScience Association (CBSA) has named Jim Kasic, Boulder iQ founder and chairman, to its board of directors. Members are selected for their leadership, and for their expertise in issues that impact Colorado’s life sciences community.
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 […]
Boulder Daily Camera, BizWest – March 10, 2021
MPO Magazine – March, 2021
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.
