The Society of Clinical Research Associates, Inc. (SOCRA)
Provides education, certification, and networking opportunities to all persons involved in clinical research activities.
American Society for Quality (ASQ)
A knowledge-based global community of quality professionals to promote the use of techniques to improve organizational quality.
Regulatory Affairs Professionals Society (RAPS)
RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.
International Organization for Standardization
ISO creates documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.
Medical Device Registration
Most recent version of the MDR along with supporting guidances.
21 CFR Part 820
Most up to date version of CFR – Code of Federal Regulations Title 21 Part 820 Quality System Regulation.
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
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 […]
