Drop the checkbox mentality and embrace accountability and understanding.
Going paperless is easier than you think.
Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
Think outside of the box and approach your QMS with passion and creativity.
If a device establishment is going to invest significant time and money into building a cleanroom or a controlled environment room, it makes zero sense not to perform proper monitoring of the environment.
A review of changes made to the standard published earlier this year.
A guide to how and why QMS software helps medical technology companies.
If you climb into FDA’s sandbox, be prepared to play by the rules.
A monumental screw up, complete with bad quality, regulatory and statutory practices.