Tell us a little about yourself and your role at Acertara? My role at Acertara is Purchasing and Inventory. My day-to-day involves ensuring that our inventory aligns with our operational needs. I get to use my organizational skills to keep things running smoothly. I’m learning new things every day! I was born and raised in … Continue reading
As medical device repair companies navigate new compliance guidance, the need for specialized technical expertise has never been clearer. The FDA’s Final Guidance on medical device repairs mandates that hospital suppliers and third-party servicers restore devices to original equipment manufacturer (OEM) specifications during servicing. For remanufacturing, the FDA requires a 510(k) clearance submission. Validating compliance … Continue reading
Precision testing plays a crucial role in the medical device industry, ensuring compliance with regulatory requirements and enhancing patient safety and treatment outcomes. In the field of ultrasound technology, precision testing extends beyond basic functionality checks to include detailed evaluations of each component, particularly at the acoustic element level of a probe. This approach objectively … Continue reading
The Corner Office Wayne Moore 8/13/2024 A tired refrain is already emerging from the world of artificial intelligence (AI): “It’s the algorithm’s fault.” I say tired because it is in our DNA to blame someone else. In the Garden of Eden when God asked Adam what he had done, he said, “the woman YOU gave … Continue reading
Tell us a little about yourself and your role at Acertara? I was born and raised in Texas, and I recently moved to Colorado seeking better weather and lower humidity to enjoy the outdoors. In my role as a Manufacturing Technician at Acertara, I build and test equipment to ensure ultrasonic probes are working properly. … Continue reading
The FDA’s Final Guidance on medical device remanufacturing has underscored the critical need for quantitative testing. This type of testing is essential to ensuring compliance with their Guidance because it verifies that devices meet stringent safety and performance standards. Achieving accurate and reliable quantitative testing isn’t feasible without the right combination of advanced technology and … Continue reading
The U.S. Food and Drug Administration (FDA) recently issued Final Guidance on the definition and determination of what constitutes “remanufacturing” for reusable medical devices. This update aims to ensure consistency and adherence to federal regulations by original equipment manufacturers (OEMs) and third-party suppliers, distinguishing remanufacturing from servicing. This distinction clearly outlines the regulatory guidance entities … Continue reading
The recent release of the FDA’s Final Guidance on remanufacturing of medical devices sent ripples through the healthcare industry. This is especially true for healthcare organizations (HCOs) heavily reliant on reusable medical devices. This new guidance aims to clarify the distinction between servicing and remanufacturing activities, both of which are crucial for ensuring patient safety … Continue reading
The FDA’s Final Guidance on repair versus remanufacturing of medical devices has important implications for hospital suppliers. It goes beyond simple terminology — new definitions and requirements have real impacts on patient safety and hospital liability. Misinformation can lead to reputational damage and even legal repercussions. Understanding the key differences between repair and remanufacturing — … Continue reading
Tell us a little about yourself and your role at Acertara. I am the Technical Sales Specialist at Acertara. I am part of the Sales team but also work closely with our 17025:2017 accredited acoustic power intensity lab, manufacturing, and engineering teams. I help OEMs, startups, and research institutions with acoustic testing services and equipment. … Continue reading