Design Verification-1
Sample Size Required for Medium Risk Characteristic Attribute Data ?
29
How many options are listed in the procedure for Variable sampling for disposables and reusable Instruments ?
4
What method is used to identify the DVAL user sample size ?
Binomial Distribution Exact method
Sample Size Required for High Risk Characteristic Attribute Data ?
44
how do you determine the risk level for a characteristic ?
DFMEA (severity occurrence ratings) and Risk management Procedure PRO-201884 (Tri-site), PRO-202098 (Austin)
What are the methods used for estimating the variable data sample sizes ?
Tolerance Interval Analysis
K-factor analysis
how many users are required for a NPD project ?
5
Sample Size Required for High Risk Characteristic Variable Data ?
30
what is the confidence level and reliability level required for Medium risk characteristic ?
95%C, 90%R
How many samples are required for documentation and labeling verification ?
1
how many users are required for a non NPD project (design changes to existing product) ?
User Sample Size depends if there is a impact to the User needs
How do you know the variable data is normal ?
Anderson Darling P-Value≥0.05
Sample Size required for Variable data Medium Risk Characteristic ?
Depends on the Mean and Standard Deviation
Sample Sizes required for Biocompatibility testing ?
dependent on the surface area of the device. refer to the Biocompatibility procedure.
what is the 90% Confidence level lower bound achieved when all the 5 users have positive (Clinical acceptable) results
55%
What is the process capability requirement for variable data ?
Cpk≥1 (normal data), or Ppk≥1 (non-normal data)
What is the method used for Attribute sample sizes ?
Bayes Success Run theorem
(C=0 Sampling plan)
Confidence interval formula
Sample Size required for IEC/EMC Testing (Disposables. Reusables and Capital Equipment)
1
what to do when one of the users have negative (Clinical unacceptable) results for a NPD project ?
1) Re-evaluate the device design with 4 additional users
2) address the root cause and re-execute Design Validation with 5 users.
what do you do if Cpk or PPk < 1 ?
Implement additional controls such as
1) increased process monitoring
2) increased sampling
3) gage inspection etc