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.
Here’s a hint: Compliance with new regulation in Europe is a high priority.
All equipment must be qualified and calibrated for its intended use.
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.
Failure to comply with FDA’s wishes landed three companies warning letters.
Throughout 2018, device and diagnostic manufacturers have opportunities to address challenging market trends and turn internal change into ways of increasing business and goodwill from providers who purchase their technology.