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 […]
510(k) Clearance
510(K) CLEARANCE CASE STUDY CHALLENGE:The manufacturer of a new laser-resistant endotracheal tube device needed to use an older predicate for their 510(k) submission to the FDA. While still commercially available, the predicate device was over 20 years old at the time of submission, with limited regulatory information and test data available. FDA often imposes closer […]
Regulatory Strategy
REGULATORY STRATEGY CASE STUDY CHALLENGE:A large international medical diagnostic system equipment manufacturer was beginning to see the fruits of a technology development collaboration with Boston-area medical research institutions. Having set up a subsidiary company in the US to commercialize these technologies, the company needed: APPROACH:AlvaMed proposed a project with: The 3-month, $60,000 project assessed the […]
GMP and CE Certification
GMP AND CE CERTIFICATION CASE STUDY CHALLENGE:A major pharma company purchased a medical device business, seeking to achieve FDA clearance, CE certification and remain compliant under GMP regulations. APPROACH:An experienced AlvaMed team developed a project plan consistent with ISO 13485 and the European Union regulations. AlvaMed’s team: RESULTS:Risk analyses and a 510(k) draft were completed […]
Large Company QMS Harmonization
LARGE COMPANY QMS HARMONIZATION CASE STUDY CHALLENGE:One of the world’s largest life science companies was experiencing a significant increase in scrutiny from the FDA. At a time when the FDA’s increased expectations of QMS harmonization within large integrated life science companies had increased, multiple audits highlighted the need for harmonization across the company’s groups. The […]
Due Diligence
DUE DILIGENCE CASE STUDY CHALLENGE:A large multi-national pharmaceutical company determined that the best strategy for a major pain-relief product was to expand associated synergistic product offerings. One product was a medical device from a small device company whose device applied a magnetic field with claims to alleviate pain and reduce inflammation. While targeting the device […]
Design Control Document Templates
DESIGN CONTROL DOCUMENT TEMPLATES CASE STUDY CHALLENGE:A medium-sized manufacturer of invasive therapeutic products wanted an improved design control process that could function well with both disposables and systems. APPROACH:AlvaMed developed an approach that made use of detailed, self-tutoring templates for all DHF document types. RESULTS:The templates have been successfully used to provide a thorough and […]
US Agent Services
FDA US AGENT CASE STUDY CHALLENGE:A startup company in France successfully completed their US market clearance for an imaging device and selected a US distributor. After registering their manufacturing establishment in France with the FDA, the company became aware of the FDA’s requirement to appoint a US Agent. Their distributor was unwilling to take on […]
