ISO

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.

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?

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...

The Flu in 2021

The Flu in 2021

‌  With Halloween behind us, the most wonderful time of year is almost here, flu season! The COVID pandemic set a...

Devices in the Digital Age

Devices in the Digital Age

‌  As the digital age continues to advance at an amazing pace, healthcare and medical devices have managed to...

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