CFR

Software as a Medical Device

Software as a Medical Device

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….

Decorative Contact Lenses

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

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

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

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…

What is ISO 13485?

What is ISO 13485?

‌  A Quality Management System (QMS) is a necessity for all organizations, not just companies that are in the...

ISO 13485 & QSR Harmonization

ISO 13485 & QSR Harmonization

For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...

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