PRODUCT TESTING AND CERTIFICATION

1. PRODUCT TESTINGANDCERTIFICATION Kenneth Crow DRM Associates

2. TYPES OF TESTING DEVELOPMENT TESTING RELIABILITY TESTING QUALIFICATION/ CERTIFICATION ACCEPTANCE TESTING TECHNOLOGY DEVELOPMENT PRODUCT DEVELOPMENT TESTING AND CERTIFICATION PRODUCTION

3. CERTIFICATION TESTING Regulations Legal Liability Specifications Standards Certification testing to assure compliance, satisfy customers, and protect against legal liability

4. Automobiles Pollution Environmental Protection Agency Safety National Highway Safety Commission Aircraft Safety Federal Aviation Administration Consumer Products Electrical Safety Underwriter’s Laboratories Defense Satisfies Require- Department of Defense ments Drugs Safety & Efficacy Food & Drug Administration Electronic Equipment RF Emissions Federal Communication Commission Medical Equipment Safety Food & Drug Administration TYPES OF CERTIFICATION & QUALIFICATION

5. TEST PLANNING TEST STRATEGY SPECIFICATIONS REGULATORY OR VOLUNTARY CERTIFICATIONREQUIREMENTS Test Plan

6. TEST PROCESS Test Plan (who, what, when) Test Procedures (how) Test Equipment/Instrumentation Design Test Equipment Acquisition/Fabrication Test Equipment Software Development Test & Document Results Analysis, Corrective Action, & Submittal

7. TESTING TO VALIDATE ANALYSIS Simulation & Analysis to mature product design Physical testing to validate Simulation & Analysis

8. Time-to-market & risk CERTIFICATION PLANNING FOR IPD • Understand certification & regulatory approval requirements • Assess unique product certification and regulatory approval requirements • Early coordination and communication with agencies and outside laboratories • Active involvement of safety engineers, regulatory affairs department, and legal • Early development of test plans and procedures • Heavy simulation and analysis to reduce physical testing • Proactive use of reliability & safety analysis - FMEA, FTA, etc.