The Corner Office Wayne Moore 7/24/2024 Heralded for months as the upcoming battle of the titans, the remanufacturing versus servicing panel discussion at AAMI featuring yours truly, Binseng Wang, and Larry Hertzler, many wondered if it would live up to the hype. Well, most felt that it did but maybe not in the way that … Continue reading
Recent FDA guidance on remanufacturing medical devices has shed light on the crucial distinction between repair and remanufacturing activities. Ensuring proper maintenance and repair of reusable medical devices is essential for both patient safety and continued functionality throughout equipment lifespan. Navigating the new guidelines and complying with the testing requirements can be a challenge for … Continue reading
In medicine, ensuring the safety and efficacy of equipment is paramount. From complex surgical tools to diagnostic instruments, medical devices play a crucial role in patient care — and the U.S. Food and Drug Administration (FDA) is at the forefront of mandating requirements to govern them. Specifically, the FDA releases guidance that sets the tone … Continue reading
Tell us a little about yourself and your role at Acertara. My name is Caden Tuttle. Originally from a small town in Illinois, I eventually ended up in Colorado after traveling around the country in a van. Acertara hired me as a dual-role position: 1) Inspection Technician and 2) Shipping and Receiving Clerk. Now, my … Continue reading
The Corner Office Wayne Moore 5/13/2024 As readers know, the FDA recently released the long-awaited final Guidance for Remanufacturing.1 Overall, the FDA took the path of outlining the requirement for servicers and repair entities (excluding hospital-based HTMs) to employ risk-based analysis of repair activities coupled with quantitative testing to determine either if the “repair” activity … Continue reading
Summary for Acertara customers The FDA guidance issued last week is a fresh and clarifying look at how to distinguish between repair and remanufacturing. The guidance document seeks to help companies engaged in these activities to understand how to interpret the existing laws that govern repair and remanufacturing. One key takeaway for Acertara customers is … Continue reading
The Corner Office Wayne Moore 5/13/2024 We are currently witnessing another transitionary anomaly, the likes of which we haven’t seen since the nascent era of the dotcom bubble. Remember the results of that bubble popping? Do you remember a company called Boo.com? It spent almost $150 million on advertising before it sold a single piece … Continue reading
In a perfect vision of society, healthcare would be universally accessible, with timely and effective treatment available to all. Yet the reality is often marred by challenges such as geographic isolation, financial constraints, and a scarcity of resources, all of which hinder access for many communities. Amid these challenges, advancements in medical technology are emerging … Continue reading
My name is Brittany, I grew up in Durango, Co but have lived in beautiful Longmont, CO for the past 23 years. I have two amazing daughters (Twins!) and I enjoy spending as much time as possible with them. I have a couple of roles here at Acertara: I am the Receptionist and Sales Assistant. … Continue reading
If the digital age has taught us anything, it’s that information is valuable — and powerful. This has always been a fundamental truth in the world of healthcare. Today, we’re seeing a marriage of digital capabilities and healthcare philosophies in pursuit of improving patient care. Nowhere is this more evident than within the scope of … Continue reading