Here’s what these three CEOs think about why the transition to digital is more important than ever.
An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR.
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
A look at the pros and cons of connected medical devices.
How manufacturing execution systems not only help with audits but also aid in production efficiency and faster product introduction.
A guide to what to expect during your certification audit and how to prepare.
The product can conduct electrocardiograms and measure the heart’s rhythms.
It is our responsibility to educate family and friends about the dangers associated with the practicing of backroom medicine.
The agency is aiming to provide more transparency and consistency in this area.