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Corrective Action Effectiveness Checks: How to Verify CAPA Worked Under FDA and ISO 13485
Corrective action effectiveness checks are the step most CAPA processes get wrong. Teams document the root cause, implement fixes, close
FDA Pre-Submission (Q-Sub) Program: How to Use It to De-Risk Your Device Submission
The FDA Pre-Submission program gives medical device manufacturers a formal mechanism to request written feedback from the agency before submitting
ISO 13485 Clause-by-Clause Breakdown: Understanding Every Section and Its QMS Implications
ISO 13485:2016 is the international standard for quality management systems specific to medical device manufacturers. Certification demonstrates that a manufacturer's
21 CFR Part 820 Design Controls: Detailed Requirements and Common Audit Findings
Design controls are among the most frequently cited areas in FDA inspections of medical device manufacturers. Under 21 CFR Part
Good Documentation Practices (GDP): What Every Employee in a Regulated Company Must Know
Good documentation practices are not a secondary compliance task. In a regulated company, the record is the product. FDA investigators,
FDA Warning Letter Case Studies: The Top Repeat Citations and What They Mean for Your QMS
FDA warning letters are public documents, and the patterns inside them are consistent enough that quality teams who read them