Regulatory Services

InnoRevision has years of expertise in FDA and IEC 62304 regulatory submissions. We offer a complete array of software documentation tailored for your: IDE, 510(k), PMA, or CE submission.  We offer this not only as part of our standard development  services, but also as a standalone service.  We are even available as a coach for your existing engineering team, and as an auditor for your final Design History File (DHF) if needed. Our processes have been proven to meet FDA 21CFR Part 820, ISO 13485 and IEC 62304 standards.

Software Verification and Validation testing is a critical part of the development cycle.  InnoRevision can help get the testing you need to prepare your product for submission or release into the real world.  Some of the testing service we offer are:

• • • PCB Circuit testing

    • Peripheral Component Testing

    • Unit and Integration Testing

    • Peer Code Reviews

    • System Error, Bug, and Anomaly Testing

    • Software Verification and Validation Testing

    • Manufacturing and Burn-In Testing

    • Field Service Testing

Years of leading Risk Analysis, for all shapes and sizes of projects, has lead InnoRevision to develop methods that make RA more effective and more efficient.  Our knowledge of ISO 14971 and the key aspects for software, and its integration into IEC 62304 complaint methodologies, allow us to focus on the Risk for your project.