How do I audit a medical device clinical investigation against ISO 14155 and GCP?
What is this resource?
An overview of a comprehensive clinical investigation audit checklist for medical device studies conducted to Good Clinical Practice and ISO 14155:2020.
Who should use it?
Sponsors, clinical quality staff, and auditors responsible for the conduct and oversight of medical device clinical investigations.
When should it be used?
When auditing a clinical investigation, when preparing a study for regulatory submission under FDA IDE or EU MDR, or when verifying safety reporting and monitoring against ISO 14155:2020.
What does it include?
- 100+ audit criteria
- GCP and ISO 14155:2020 coverage
- FDA IDE and EU MDR submission alignment
- Safety reporting: AE, SAE, SADE, USADE
Need more than a template?
SA Quality Solutions provides implementation support, gap assessments, internal audits, and remediation services for FDA QMSR, ISO 13485, MDSAP, and EU MDR. If you would rather have this done with you than do it yourself, a 30-minute discovery call is available at no cost.
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