Medical Devices

Medical Device Services Portfolio:

  • Medical Device Clinical Investigational Studies
    • Feasibility Studies,
    • Pilot Studies, PASS Studies
    • Clinical Follow-up Performance Studies
  • Real-World Evidence Studies
  • PMCF Studies
  • Regulatory Submissions
    • Product Registration
    • Import/Export
  • Investigational Device Exemption (IDE)

USFDA 510 (k) Submissions:

  • De-novo 510 (k) Submissions
  • PMA Submissions
  • Manufacturing License
  • Loan Manufacturing License Approvals
  • Medical and Scientific Writing Services
  • CER (Clinical Evaluation Report) Writing
  • Literature review summaries on Analytes
  • PER Performance Evaluation Reports
  • PMCF Post-marketing Clinical follow-up plans and reports for Class IIa, IIb, III Devices
  • Device Vigilance & PSUR Writing
  • Toxicology Reports Writing
  • Audits and QMS Services (ISO13485:2016)

EU-MDR and IVDR Consulting Support:

  • Artwork & Label Management
  • EU PMS FSCA Reporting