In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
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EU MDR SSCP’s: The Importance of Readability
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.
Investigational Device Exemption
An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data….
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...
The Value of Validation in a QMS
The FDA defines validation as a process required to establish documented evidence that provides a high degree...
Understanding Label Claims
Claims are defined statements, symbols, or wording that are made on a product. They can be advertising,...
Label Warning for Pfizer and Moderna
Last week, the FDA announced that Pfizer-BioNTech and Moderna will require warning labels for vaccines for young...
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...
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