Data

Key Performance Indicators Unlock Potential

Key Performance Indicators Unlock Potential

There are right and wrong approaches for using measures to achieve performance improvement. Knowing the difference requires some book-learning, but mostly the wisdom of broad and deep experience.

The Digitalization of Quality Management Systems

The Digitalization of Quality Management Systems

One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.

HIPAA and GDPR’s impact on Medical Devices

HIPAA and GDPR’s impact on Medical Devices

The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.

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….

Principles of Data Integrity

Principles of Data Integrity

Data integrity is one of the most critical factors in any regulated industry. This is because any data error could...

QMS Tips

QMS Tips

‌  Every organization that manufactures medical devices, pharmaceuticals, biologics, cosmetics, or other types of...

Pop Healthcare

Pop Healthcare

‌  For a long time, healthcare was in the hands of doctors. People listened only to their doctor’s advice on how...

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