Top 3 Mistakes You Can Make When Adopting ISO 13485
Drop the checkbox mentality and embrace accountability and understanding.
Tag Archives: QMS
Choosing The Right QMS For Your Medical Device Company
Going paperless is easier than you think.
Using Agile Values for Medical Device Development
Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
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.
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.
