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.
If an activity is not documented, it did not happen.
When responding to a 483 observation, clarity is a must: Both in communication and documentation.
Documentation proves compliance, including when it comes to acceptance activities.
Don’t overlook this critical practice.
A three-part series on quality system remediation and what manufacturers need to do to get through the process.
The document clarifies the MDR regulation and reporting requirements for medical device companies.
If you’re thinking of handing unsigned documents to FDA during an inspection, think again.
Define, document and implement!
Documented evidence of compliance is your best friend during an agency inspection.