target group
Product developers (verification of products), test planners (production monitoring and product release) and process managers (process validation).
content
The properties of medical devices and their manufacturing processes must be verified "with a high degree of certainty". "High certainty" means that all essential quantitative properties must be verified with a meaningful sample size. A justification based on statistical methods must be given for these quantities. If the corresponding measurements have been carried out, the question of the statement of the test automatically arises in the case of variables subject to scattering. Is it sufficient if all subjects are within the specification limits? Does the release have to be rejected if a single reading violates the spec? Which statement can be derived for the total amount of products? This seminar provides simple basics for understanding the statistical methods that can be used to answer these questions.
topic overview
- Normative requirements (21CFR820; DIN EN ISO 13485)
- Type test, performance test
- Statistical Basics
- Hypothesis Test | Normal distribution, mean, standard deviation, confidence level
- Risk-oriented approach
- sample sizes | standard procedure
- DIN ISO 3951 (Sampling Inspection by Variables)
- ANSI/ASQ Z1.4 (Sampling Procedures and Tables for Inspection by Attributes)
- ANSI/ASQ Z1.9 (Sampling Procedures and Tables for Inspection by Variables)
- Squeglia, C=0 (Zero Acceptance Number Sampling Plans)
- ISO 16269-6 (determination of statistical proportion areas)
previous knowledge
Not mandatory.
KONTAKT:
Online
