1. PRODUCT TESTING AND CERTIFICATION Kenneth Crow DRM Associates

2. © 1998 DRM ASSOCIATES TYPES OF TESTING TECHNOLOGY DEVELOPMENT PRODUCT DEVELOPMENT PRODUCTIONTESTING AND CERTIFICATION DEVELOPMENT TESTING RELIABILITY TESTING ACCEPTANCE TESTING QUALIFICATION/ CERTIFICATION

3. © 1998 DRM ASSOCIATES CERTIFICATION TESTING Standards Specifications Regulations Certification testing to assure compliance, satisfy customers, and protect against legal liability Legal Liability

4. © 1998 DRM ASSOCIATES TYPES OF CERTIFICATION & QUALIFICATION AutomobilesPollutionEnvironmental Protection Agency SafetyNational Highway Safety Commission AircraftSafetyFederal Aviation Administration Consumer ProductsElectrical SafetyUnderwriter’s Laboratories DefenseSatisfies Require-Department of Defense ments DrugsSafety & EfficacyFood & Drug Administration Electronic EquipmentRF EmissionsFederal Communication Commission Medical EquipmentSafetyFood & Drug Administration

5. © 1998 DRM ASSOCIATES TEST PLANNING TEST STRATEGY REGULATORY OR VOLUNTARY CERTIFICATION REQUIREMENTS SPECIFICATIONS Test Plan

6. © 1998 DRM ASSOCIATES 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. © 1998 DRM ASSOCIATES TESTING TO VALIDATE ANALYSIS Simulation & Analysis to mature product design Physical testing to validate Simulation & Analysis

8. © 1998 DRM ASSOCIATES 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. Time-to-market & risk