Statistical Procedures for the Medical Device Industry (emailed pdf only)
Provides statistical procedures designed to ensure that all statistical regulatory requirements for medical devices are met. These regulatory requirements can be found in:
Code of Federal Regulation 21CFR, Part 820 Quality System Regulations
ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes
Company licenses to these procedures are also available.
Policy and General: STAT-01 is the general policy procedure and STAT-02 provides definitions used by the procedures.
STAT-01 Statistical Policy
STAT-02 Glossary of Statistical Terms
Areas of Application: STAT-03 to STAT-11 describe the statistical requirements for each area of application. They may also provide statistical techniques that are specific to that area of application or reference a supporting statistical technique procedure.
STAT-03 Statistical Techniques for Process Validation
STAT-04 Statistical Techniques for Design Verification
STAT-05 Statistical Techniques for Component/Material Qualifications
STAT-06 Statistical Techniques for Design Validation
STAT-07 Statistical Techniques for Audits and Effectiveness Checks
STAT-08 Statistical Techniques for Test Method Validation
STAT-09 Manufacturing Acceptance Sampling Plans and Inspections
STAT-10 Statistical Techniques for Tending Data
STAT-11 Statistical Techniques for Setting Specifications
Supporting Statistical Techniques: STAT-12 to STAT-19 describe specific statistical techniques. They do not specify any additional requirements beyond those in the policy and application procedures.
STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming
STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities
STAT-14 Verification/Validation Sampling Plans for Average
STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD
STAT-16 Statistical Techniques for Equivalence Testing
STAT-17 Statistical Techniques for Reliability Life Testing
STAT-18 Statistical Techniques for Normality Testing and Transformations
STAT-19 Rounding of Data