Device Classification
Background and Problem A US based manufacturer of sample preparations reagents and instruments needed an outside opinion of their regulatory compliance regarding labeling certain devices as “Research Use Only (RUO)” in the United States and the European Union. The manufacturer also wanted assistance to develop an approach on how best to register and list a […]
Regulatory Strategy & 510(k) Submission Support
CHALLENGE: A new US based division manufacturer of a Chinese dental implant, wanted to grow their business by bringing their product, material used in the construction of dental implants, to the US market. With no prior experience in US medical device regulations, they needed assistance determining the best regulatory path and guidance to navigate the […]
ACLA’s Bold Move: Challenging FDA’s Final Rule on LDTs
In a groundbreaking legal maneuver, the American Clinical Laboratory Association (ACLA) has filed the first lawsuit in an attempt to block the implementation of the Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs). The contentious Final Rule, which aims to regulate LDTs, has sparked heated debates within the healthcare and regulatory […]
MHRA Launches AI Airlock: Pioneering Innovation in Regulatory Oversight
The Medicines and Healthcare products Regulatory Agency (MHRA) has taken a bold step into the future of regulatory oversight with the launch of the AI Airlock initiative, a new regulatory sandbox designed to help understand risks related to AI as a Medical Device (AIaMD). This groundbreaking endeavor marks a significant leap forward in harnessing the […]
Accelerating Clinical Trials in the EU: Two Pilots Go Live
Clinical trials are the cornerstone of medical innovation, driving the development of new treatments and therapies that improve patient outcomes and advance healthcare. However, the traditional clinical trial process is often lengthy and complex, posing significant challenges for researchers, sponsors, and patients alike. The COVID-19 era brought a decrease in multi-state clinical trials applications in […]
MDR Compliance
Challenge: A long-standing client, a small company specializing in innovative minimally invasive endosurgical devices, needed to maintain their existing CE Mark while updating their QMS to comply with the new Medical Device Regulation (MDR). Facing limited resources to implement the new regulations and update their documentation for an MDR submission, they trusted AlvaMed’s proven track […]
Clinical Evaluation – Single-Use Overtube
This case study exemplifies AlvaMed’s ability to guide clients through intricate regulatory landscapes, ensuring compliance and accelerating market entry.
Class III FIH Trial
CLASS III FIH TRIAL CHALLENGE:A Class III medical device startup required clinical affairs and submission support for a First in Human (FIH) study to evaluate a novel neurology implant. The company made the strategic decision to do initial clinical evaluations outside the US to prove out the device design and use the data to support […]
IDE Study CHALLENGE:A medical device startup required expertise in designing, managing, and executing an investigational device exemption (IDE) study for their tissue-ablation device. The IDE clinical trial was conducted to add a new indication for the device (treating walled off pancreatic necrosis by performing direct endoscopic necrosectomy). The device had been previously approved in the […]
Clinical Study Management
CHALLENGE:A small medical device start-up required support planning, managing, and executing a post-market clinical study for their Endoluminal Occlusion System (EOS™) devices. The sponsor required an immediate plan to transition the ongoing study to AlvaMed and to open up a new treatment arm for the study. A project plan and tracking tools needed to be […]
