The DMR is nothing more than the recipe (a.k.a. secret sauce) while the DHR is documented evidence of compliance.
How do you find meaningful signals in the middle of masses of noise, correctly interpret those signals and apply them for a useful purpose?
There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.
There really is no excuse for receiving a Form 483 observation for management review.
The medical device industry has more than its share of challenges, from regulations and changing business environments to the need to drive down costs and compete on price, all the while accelerating their ability to accelerate the process from order entry to order fulfillment.
The removal of communication barriers and ambiguity allows technology providers to focus on their own inherent system benefits.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?
By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.
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.