Medical devices

Regulatory Affairs for Medical Devices

  • Import/ Export
  • Registration


Quality Management

  • CE Mark
  • ISO 13485


Clinical Research

  • Clinical Trials
  • Data Management
  • Medical Writing

  • Financial Support
  • Moral Support
  • Emotional Support
  • Reimbursement Assistance
  • Collection, investigation, and assessment of medical device
  • Incidents
  • Submission of medical device incidents to Competent Authorities
  • Expedited Reporting to Authorities
  • Follow up and/or final report management
  • Training
  • Field safety corrective action generation and submission
  • Creation and distribution of Field Notices (FSNs)
  • Preparation of Periodic Summary Reporting
  • Liaison with authorities
  • Writing and/or reviewing Standard Operating Procedures
  • Audits/inspections and training on Medical Device Vigilance
  • Trend Reports to National Competent
  • Working as Responsible person
  • Storage and protection of medical device incidents records
  • Literature search
  • Contact point with the Notified Body about