Regulatory & Testing Services

We manage the entire application preparation and submission process

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 process to secure certification swiftly for your product.

We can help you with:

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

  • 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

Complete solution services including product regulatory testing and clinical evaluation for FDA approval and CE marking