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. After almost 10 years at our previous location in a multi-company facility, we purchased our own building, allowing us to install much larger and more diverse equipment and capabilities.
- We now have over 2000 square feet of clean room manufacturing area
- We have a new quick-turnaround ethylene oxide sterilization center, the only one between California and the East Coast
- We established the Boulder Medical Device Accelerator (see www.bouldermda.com) to help nurture select start-up and emerging companies
- We significantly upgraded our Regulatory Affairs department, adding Dr. Mike Andrews as leader of the team with his extensive background overall, nationally and internationally, plus his experience as a medical device review executive with the FDA
We’re in position to grow dramatically in 2021. We will be doubling our sterilization capabilities (again), while maintaining our best-in-the-industry 4-day turnaround for EO sterilization runs. We have final assembly and packaging capabilities to support placing product into sterilization, and our engineering team is ready to design or help you design your products from concept to production release. Plus, as noted at the top of this newsletter, the EU Medical Device Regulations go into effect this year as well and Boulder iQ has a step-by-step, efficient approach to evaluate your readiness and help you get there!
If you’re not familiar with Boulder iQ I invite you to contact us so we can show you what we can do for your company. If you’re a virtual company just getting started, we can provide full support services including design, qualification, manufacturing, regulatory clearance and release. If you’re a well-established company, we can provide design and qualification assistance and unparalleled speed in performing your ethylene oxide sterilization runs for various test purposes. If you’ve had regulatory issues such as form 483 observations or a Regulatory Letter, we’re here to help, if you need to address the new EU Medical Device Regulations, we have highly efficient programs to help you achieve compliance.
Take a look and we believe you’ll want Boulder iQ to become your trusted medical device partner. We will be honored to support you!
My best wishes for a safe and prosperous 2021 to you all!
Jim Kasic, CEO