Small medical device companies confront daunting product development and labeling issues. We understand the special needs of smaller medical device companies. Our FDA consultants take a holistic approach that considers a company’s marketing objectives and the current FDA’s regulatory, compliance, and enforcement environment.

Our FDA Consultants are highly experienced in the specialized requirements for medical device labels. With our detailed knowledge of FDA labeling requirements, we can review your packaging, product insert and device label as well as appropriateness of claims, ensuring your product’s labels are in compliance with regulations and Indication for Use (IFU) as cleared/approved by the FDA.

We help small companies navigate the medical device labeling maze to help ensure compliance with FDA labeling regulations. Our FDA consultants can also assist the medical device companies to obtain a Unique Device Identifier (UDI) code that is in human- and machine-readable form, that allows accurate identification of products during postmarket surveillance.