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Regulatory & Testing

Regulatory & Testing Services

We provide complete solution through the entire application preparation and submission process including product regulatory testing and clinical evaluation for FDA approval and CE marking.

Our engagement model

Our consulting process will be like an engineering design partner working with you closely to monitor and accelerate regulatory testing and submission pro cess to secure certification swiftly for your product.

We can help you with

  • FDA 510 (k)clearance for Medical devices.
  • CE marking approval.
  • ISO 14971:2007 Risk Management.
  • Product Regulatory testing.

Technical files : US FDA 510 (K) clearance

  • Developing an effective strategy for submission - 510(k) or PMA
  • Product specific background research
  • Technical file or design dossier completion and review
  • Design verification and validation testing input
  • Documentation preparation (all required for 510 (k) sections)
  • QSR, GMP Guidelines

European CE Marking

  • CE marking Technical file or design dossier completion and review
  • Verification of essential requirements
  • Implementation and maintenance of ISO 13485 requirements
  • Product labeling and packaging review
  • Vigilance and post market surveillance

ISO 14971: 2007

  • Intended use review
  • Identifying hazards
  • Estimate probability and severity occurrence
  • Control and monitoring risks
  • Risk chart
  • Risk management report preparation

Product Regulatory testing

  • Device Classification
  • Compliance standards identification
  • Design Analysis
  • Pre-compliance testing & report
  • Product safety Testing from accredited Labs
  • EMC Testing