REGULATORY AFFAIRS & QUALITY ASSURANCE

We offer a wealth of experience in development and management of FDA/ISO-compliant quality systems, regulatory filings and clinical study programs.

Regulatory Management

  • FDA Product Classification Assessment
  • Regulatory Plan
  • Regulatory Submissions: 513(g), Q-Sub, 510(k), IDE, PMA, eCTD, CER, PMS/PMCF
  • Marketing approvals from FDA, Notified Bodies (CE Mark), Health Canada, MHRA, MHLW, TGA,SAMR, KFDA, ANVISA
  • Clinical Study Management

Quality Assurance

  • Quality Management Systems (QMS)
  • QMS Maintenance and refinements for efficiency
  • ISO 13485, MDSAP Planning and Audit Support
  • Risk Analysis & Risk Management Plan (ISO 14971, ISO/TR 24791)
  • Biocompatibility Support (ISO 10993)
  • Human Factors/Usability (HE75)
  • Design Controls (product & Process validation/verification)

Clinical Research, Clinical Trials & Approvals

  • Clinical Study Design, Protocol and Informed Consent Development
  • IRB/Ethical Committee Approval
  • Statistical Support for Study Group Sample Size
  • Q-Sub & IDE Planning and Approval
  • Study Site & Data Integrity Management (with CROs) through all study phases
  • Statistical Analyses of Data
  • Clinical Summary Report & Product Labeling
  • 510(k), Original PMA, PMA-Supplement, eCTD for CE Mark
  • Clinical Evaluation Report (Meddev 2.7/1 (4)
  • Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF)
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