CER and Literature Search Remediation
Challenge: Approach: AlvaMed implemented the following approach: Results: AlvaMed delivered the following: Impact: Project is a heavy time burden and lift for a company, especially if they are limited with resources to dedicate to this type of remediation effort. Also, it allows a group of experts to step in, who deal with these types of […]
Case Study: Navigating Regulatory Challenges to Achieve FDA Clearance
Background and Challenge: A medical device manufacturer sought FDA clearance for its innovative lidocaine delivery device designed to deliver aerosolized lidocaine to the upper airway to facilitate office-based procedures. The company initially engaged with a different consulting company to prepare and submit the 510(k) application. However, after receiving an Additional Information Needed (AIN) letter from […]
Clinical Strategy & Protocol Development
Challenge: A small company specializing in an innovative robotic platform technology for precision surgery in oncology approached AlvaMed for CRO support. The client’s goals were to develop a clinical strategy and a study protocol with support documents (consent, Case Report Forms (CRFs), regulatory documentation) aligned with that strategy. Additionally, they wanted to have a study-ready […]
Internal Auditing
Background and Problem A small start-up with limited resources needed assistance with conducting its required internal audits to maintain compliance with quality and regulatory requirements. The scope of the organization’s quality management system includes ISO 13485:2016 and 21 CFR Parts 820, 803, & 806. Due to the size of the organization and the operating mode, […]
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 […]
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 […]
