With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
Procedures for design validation must address risk analysis where appropriate.
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.
Although not always subject to receiving inspection, defining control of non-inventory items, such as manufacturing materials, is critical.
Documentation proves compliance, including when it comes to acceptance activities.
Denying the agency to inspect your facility is a violation.
Furry critters have no place in a medical device manufacturing facility.