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.
A guide to how and why QMS software helps medical technology companies.