An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
Labeling
Label Changes and the 510k
Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device itself...
Regulation and Labeling
Complying with all regulatory requirements for a regulated product is a massive challenge. Meeting all labeling...
Labeling Compliance of CBD Products
One of the main reasons the Federal Food and Drug Administration issued warning letters to CBD companies or...
A Brief Guide to Quality Objectives
As 2021 has come to a close and companies are holding and finalizing their last management reviews, quality...
Symbols for Medical Device Labels
Labeling for medical devices is under strict regulations. The requirements are dependent on the class of...
Design and Development Planning
Developing a Design and Development Plan is a part of the design controls process required by the FDA for...
Understanding Label Claims
Claims are defined statements, symbols, or wording that are made on a product. They can be advertising,...
Complying with Medical Device Labeling Requirements
A critical, yet often overlooked, part of bringing your medical device to market is ensuring it complies with all...
Australia’s TGA Introduces UDI
Following the US FDA and now the EU Commission’s EUDAMED, Australia’s Therapeutic Goods Administration (TGA) also has...
FDALabel – The Full-Text Web-Based Tool to Search Labelling Documents
Web-applications: These are simple computing tools that are designed and built for solving human problems and...
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