FDA Registration: MedTech Edition
The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of medical devices. Medtech manufacturers must comply with FDA regulations. In this article, we will discuss the registration process for medtech manufacturing, its importance, and how to verify a company’s registration status. Understanding the Registration Process The registration […]
What to Expect at BIOMEDevice Boston 2022
BIOMEDevice Boston is back for 2022! Featuring more than 200 exhibitors and 30 industry thought leaders, this two-day event runs from September 28-29 at the Boston Convention & Exhibition Center. We’re proud to exhibit at this premier event that brings together the brightest minds in the medical device industry in one place. This post previews […]
What to Know Before Starting a Guidewire Grinding Project
Guidewire grinding is a specialized process for achieving extremely small diameters and intricate configurations for life-saving devices. The process requires incredible knowledge and skill to ensure part accuracy and cost-effectiveness. With both lives and profits on the line, guidewire grinding can often be a high-stakes project management endeavor. If you’re overseeing a high-stakes guidewire […]
How We Successfully Produced Life-Saving Bend-Free Vascular Guidewires When Others Failed
When a Salt Lake City-based biotechnology firm approached us in 2019, they were working with our competitor to help them manufacture specialty neurovascular guidewires, a critical device component designed for two stroke intervention procedures: thrombectomy and endovascular coiling. Upon reconnecting with them a year later, the firm revealed that their current vendor was struggling to […]
Introducing Our New ISO 14644 Cleanroom
When we said we were committed to continually fulfilling customer requirements and improving our quality management system, we took this promise to heart. To us, continuous improvement isn’t merely an industry buzz phrase – it’s our reality, as evidenced by the latest advancement in our production process: a new ISO 14644 cleanroom. Our new cleanroom […]
