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.
Being in compliance means operating your business in a manner that means less risk, better quality, safety and governance. Compliance management software is designed to help foster this concept, so what do you need it to be?
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.