What the New EPA Ruling on EO Emissions Means for You – and What to Do March 20, 2024 Last week, the U.S. Environmental Protection Agency (EPA) announced a rule that will put in place the strongest measures to date for ethylene oxide commercial sterilization facilities – a rule that has medical device manufacturers worrying […]
Conversations to Connections: Delving into Enthusiasm and Sterilization Solutions at MD&M West 2024 March 14, 2024 Earlier this month, Boulder iQ exhibited at the MD&M West trade show in Anaheim, California. For three days, I was surrounded by some of the most interesting, innovative people and companies I’ve met in the medical device industry. I came […]
Boulder Sterilization Offers Ethylene Oxide, Chlorine Dioxide Service More choices. More options. Better results. May 30, 2023 Boulder Sterilization is introducing chlorine dioxide (CD) service this summer, making it the sole contract sterilizer to offer CD and ethylene oxide (EO) technologies for the sterilization of medical devices and in-vitro diagnostic products. Our CD sterilizer is […]
Team Member Spotlight: Steve Seyer, Chief Operating Officer March 27, 2023 With decades of experience in the medical device industry, working at companies ranging from start-ups to larger manufacturers, the one area Steve had never explored was the consulting side of the business. That curiosity and interest led him to Boulder iQ. “I was intrigued […]
The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One Part 2: Planning for the Meeting(s) Part 1 of “The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One” covered how to tell if – and when – to request a Q-Sub meeting, including whether […]
What Does the End of the COVID Public Health Emergency Mean for Emergency Use Authorizations? February 27, 2023 I remember listening to many predictions after the Department of Health and Human Services (HHS) issued the COVID-19 public health emergency Jan. 31, 2020. None of them included that it would last for more than three years! […]
What is the Product’s Intended Use?…a Simple Question With a Big Impact on the Success of Your Regulatory Strategy February 27, 2023 You’ve no doubt heard the old adage, “measure twice and cut once.” It applies to many things, including the creation of a regulatory strategy. After 35 years in the industry, including teaching regulatory […]
Success Story: Boulder iQ Helps Hubly Surgical Assemble, Package and Sterilize Advanced Cranial Drill January 29, 2023 Cranial drilling, a widely used technique in neurosurgery, calls for precision of the highest degree in both the process and the equipment. Hubly Surgical, based in Lisle, Illinois, is the developer and manufacturer of the first and only […]
Rapid Prototyping Materials: Are They Compatible With EO Sterilization? January 29, 2023 Rapid prototyping (RP) is, yes, we’ll say it, rapidly becoming mainstream in medical device development. Defined as the technique used to quickly fabricate a physical part or assembly, RP generally relies on an additive manufacturing process – commonly known as 3D printing – […]
From the Desk of Jim Kasic December 6, 2022 December 2022…It’s hard to believe it’s been almost three years since the onset of the COVID-19 pandemic. To say the medical device industry – let alone the world – has gone through upheaval is an understatement. But as we close out the year and toward 2023, […]
