EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
Tag Archives: QMS
Beyond the Checkbox
Think outside of the box and approach your QMS with passion and creativity.
Is Your Cleanroom Clean? Prove it!
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.
Quick List: The Update on ISO 13485:2016
A review of changes made to the standard published earlier this year.
QMS Doesn’t Have to Be So Difficult
A guide to how and why QMS software helps medical technology companies.
Detention Never a Good Thing, Even for Medical Devices
If you climb into FDA’s sandbox, be prepared to play by the rules.
Fail to Respond to Form 483 Observations and Win a Warning Letter
A monumental screw up, complete with bad quality, regulatory and statutory practices.
What are the 4 Key Elements in Compliance Management Software?
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?
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?
Top Ten Tips + 1 for Medical Device Outsourcing
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
Follow these eleven tips when outsourcing to your vendors. They will save you heartache, frustration, and money.
