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 (ā€œ483sā€) and warning letters, device hazard analysis, traceability analysis, Verification and Validation, Computer System Validation, internal audit and external assessment support.

Services offered:

  • Audit
  • Risk Assessment Analysis (risk index calculations, functional risk assessment, site-applicable assessment)
  • Gap Assessment
  • Gap Analysis
  • Protocols, work instructions, and standard operating procedures development
  • Computer System Validation and 21 CFR Part 11

Optra Health regulatory experts have extensive experience with:

  • IEC 62304, QSR regulations
  • HL-7, 21 CFR Part 11,Annex 11 and MHRA conformance for data security, accessibility and audit trail
  • HIPAA compliance and the EU directive on data protection
  • GAMP - guide for validation of automated systems, Feb. 2008
  • 510 (k) application drafting and submission

Optra Health supports regulatory compliance mandates across the Medical Devices and Lab Automation industry:

  • Medical devices - Quality management systems - ISO 13485:2003
  • Health Insurance Portability and Accountability Act: HIPAA - 45 CFR Parts 160, 162, and 164
  • Medical device software life cycle processes - IEC 62304: 2006
  • Medical devices risk management - ISO/IEC 14971-1
  • Medical electrical equipment, requirements for safety - IEC 60601-1
  • Electronic records and electronic signatures - 21 CFR Part 11

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