ISO 13485 – Knowledge Check
25 questions on ISO 13485:2016: its purpose and vocabulary, the clause 4 to 8 structure, design and development controls, purchasing, process and software validation, complaints and CAPA, certification and regulatory use (EU, FDA QMSR, MDSAP), and good and bad implementation practice. Pass mark 70 %.
25 questions · 45 minutes · 2 attempts · pass mark 70%. Free: sign in to start. Your score, the correct answers and an explanation for every question appear as soon as you submit; 70% or more unlocks your certificate.
Completion requirements:
- Receive a grade
- Receive a passing grade
Attempts allowed: 2
Time limit: 45 mins
Grading method: Highest grade
Grade to pass: 70.00 out of 100.00