Software-related medical devices are taking over the medical device industry. There are three types of software-related medical devices in the industry software as medical devices, the software is integral to medical devices, and software used in the manufacturer or maintenance of a medical device1. Software that is….
CFR
Decorative Contact Lenses
Decorative contact lenses are a known medical device and are treated with the same standards as corrective contact lenses. Decorative lenses are also known as
Water for Pharmaceutical Use
When determining which type of water system is needed for pharmaceutical manufacturing it is important to keep in mind how the water will be applied to the product.
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….
Concepts of Modern Quality systems
A quality system’s main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve…
Changes to OTC Sunscreen Labeling
OTC Sunscreen manufacturers can expect to see some major changes coming their way soon, with the announcement...
What is ISO 13485?
A Quality Management System (QMS) is a necessity for all organizations, not just companies that are in the...
Pharmaceutical Temperature Mapping
Temperature mapping has become increasingly integrated into regular operations for those who produce or handle...
A QMS Should be Unique, not Universal
Implementing a Quality Management System (QMS) affects every aspect of an organization, including meeting quality...
Trends In 2020 FDA Pharma Warning Letters
The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical...
ISO 13485 & QSR Harmonization
For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...
Electronic Signatures Under 21CFR§11
In the work from home era, we all realized how important it is to digitize our important documents and what a...
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