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Engineering Consulting
Platinum AI provides consulting support for next-generation medical device development, including AI-enabled solutions, helping teams improve design, validation, and program execution from concept through launch.
Design Verification and Validation
End-to-end V&V support including test method development, protocol writing, traceability matrix creation, DHF documentation, and gap remediation. We ensure your design outputs meet design inputs and your documentation is audit-ready for FDA submission.
Process Validation and Manufacturing Operations
IQ/OQ/PQ validation support for manufacturing equipment and processes.We help medical device companies establish compliant, repeatable manufacturing processes that meet FDA 21 CFR Part 820 and ISO 13485 requirements.
Project Management and Program Leadership
Cross-functional program leadership from development through commercial launch. We manage scope, timelines, budgets, and stakeholder communications, keeping your program on track and your team aligned.
Test Method Validation
Develop and validate test methods to ensure they are accurate, reliable, and suitable for their intended use in regulated medical device environments. We establish documented evidence that testing produces consistent, reproducible results that meet FDA and ISO standards and can withstand regulatory scrutiny.
DHF Remediation
Review and remediate Design History Files to identify and close gaps in documentation, traceability, and regulatory compliance before they become audit findings. We rebuild requirements traceability, update verification protocols and test reports, and ensure your DHF is complete and audit-ready for FDA inspection or submission.
Regulatory Submissions
Support medical device companies through FDA regulatory submissions including ensuring all verification, validation, and design documentation are complete, traceable, and audit-ready. We ensure all submission requirements are addressed including sterility, biocompatibility, extractables and leachables, electrical safety, EMC, software validation, risk management, and performance testing
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