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IEC 62304, 510 (K) QSR regulations
HIPAA compliance & the EU directive on data protection
GAMP - guide for validation of automated systems
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| Home > Services > Regulatory Compliance |
OPTRA’s Regulatory Compliance service helps clients to meet regulatory requirements, get their products to market quickly and to maintain FDA compliance status. OPTRA’s extensive experience in the LifeScience and HealthCare arena, combined with regulatory knowhow, domain expertise with software engineering skills and a pioneering global delivery model, enables you to minimize time and costs, thus ensuring that you do more with less.
| Optra’s regulatory consultants have extensive knowhow on: |
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IEC 62304, 510 (K) QSR regulations, HL-7, 21 CFR Part 11 & MHRA conformance for data security, accessibility and audit trail |
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HIPAA compliance & the EU directive on data protection |
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GAMP - guide for validation of automated systems, Feb. 2008 |
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| Optra’s Regulatory Compliance services: |
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Product functionality assessment in view of regulatory requirements |
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Identifying and analyzing Predicate Device |
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Benchmarking substantial equivalence |
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Determine Level of concerns |
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Preparing Pre-IDE and liason with US FDA to seek their comments |
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Defining QSR requirements and documentation |
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Providing documentation template based on level of concerns |
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Device hazard analysis reporting |
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Unresolved anomalies parameters and Reporting |
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Define the level of details in each document in consultation with customer |
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Review and Auditing documentation |
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Traceability analysis |
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21 CFR Part 11, & MHRA conformance for data security, accessibility and audit trail |
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HIPAA compliance & the EU directive on data protection |
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Consultative services for the premarket notification submissions 510(k) for software and class II medical devices: |
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Identification and assessment of Predicate device |
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Substantial concordance with Predicate device |
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Sotware documentation efforts |
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Liasoning with FDA officers closely to ensure compliances with documentation norms and procedures |
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Statistical analysis and data presentation |
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QSR review and subsequent compliances |
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