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System Safety, Inc. services cover the entire development lifecycle of medical devices. For conception through implementation and regulatory approval, SSI assist in designing internationally compliant, state of the art instruments. We are specialized in providing:

bulletInternational Requirements Consulting
bulletHazard Analysis / Risk Analysis (to FDA and MDD requirements)
bulletRisk Management Services
bulletDevelopment And Implementation of Standard Operation Procedures (SOPs)
bulletQuality And Safety Engineering Concurrent To Device Development
bulletSoftware Verification And Validation (V&V), Incl. Test Planning
bulletSoftware Criticality Analysis / Critical Path Analysis
bulletHardware evaluation FMEA, FMECA, FTA
bulletDesign Reviews And Software Walk-Throughs
bulletThird Party Audits And Assessments
bulletNotified Body  / FDA Compliance Consulting  and Submissions
bulletFunctional Safety Testing
bulletTraining

We have been working with any major US device manufacturer in the past and our experience helps you to avoid mistakes others have made. 12 years experience in medical device safety are at your disposal.  Please check our references and our device catalog.

 

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