Regulatory compliance can be achieved easily and hassle-free by outsourcing to a strategic partner with an in-house team of dedicated regulatory experts and consultants, documentation experts, auditors, legal experts and liaison officers.
Optra Health has a proven track record of helping clients meet regulatory requirements and getting their products to market quickly to maintain FDA compliance status. Optra offers a broad range of solutions and services at every step of the regulatory process spanning from product assessment and classification, identifying predicate device, benchmarking substantial equivalence, preparing the pre IDE document and serving as liaison with the FDA for the pre IDE meeting, defining QSR requirements and supporting QSR documentation, FDA inspectional observations (“483s”) and warning letters, device hazard analysis, traceability analysis, Verification and Validation, Computer System Validation, internal audit and external assessment support.
Optra Health regulatory experts have extensive experience with:
Optra Health supports regulatory compliance mandates across the Medical Devices and Lab Automation industry:
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