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 […]
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, […]
The Lure of the FDA Q-Sub Meeting: When (and When Not) to Call for One Part 1: Timing considerations Jim Kasic, CEO & Chairman, Boulder iQ Ah. The Q-Sub. The FDA loves Q-Sub meetings, manufacturers love to get FDA input and they’re free. What’s the issue? There is no issue – when product developers use […]
Second Sourcing EO Sterilization: From the desk of Jim Kasic Jim Kasic, CEO & Chairman, Boulder iQ I’m a pilot. My son and I flew to the Sawtooth Mountains over Labor Day to do a 4-day backpacking trip. The air strip that we landed on is only accessible by plane, foot or horse. If anything […]
