Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.
An adequate structure must be in place to support a QMS.
A review of changes made to the standard published earlier this year.
How to prepare for a successful transition.
If you climb into FDA’s sandbox, be prepared to play by the rules.
You need a management representative with oversight over medical device quality.
Risk Management is the single most important topic impacting the medical device industry today.
It is incumbent upon your organizations to ensure that the classifications of devices entered into commerce are properly classified and the applicable QMS requirements understood and implemented. Class I or Class II exempt has nothing to do with the actual QSR requirements and pertains only to the regulatory pathway.
There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.