Does your company understand the magnitude of the compliance effort?
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
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.
Following protocols and maintaining compliance have been common themes.
It is one of the most basic of quality requirements.
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
How simple labeling changes can drive big results for medical device manufacturers.
Think outside of the box and approach your QMS with passion and creativity.