Device Vigilance

Device Vigilance

SERVICE OVERVIEW

Device Vigilance Services

Improving Protection

SAR Tech provides a wide range of Device Vigilance services. We offer both clinical and post-authorization support. We are specialized in CE-marked, non-CE marked, Implantable, In Vitro Diagnostic Medical Devices and drug-device combination products in compliance with both EU MEDDEV guidance and FDA 21 CFR 803 and 812 standards.

Our services include:

  • Collection and evaluation of incidents
  • Adverse Device Effect (ADE) / Medical Device Incident (MDI) Case Processing
  • Reporting incidents
  • Detection and reporting of trends
  • Field Safety Corrective Actions (FSCAs)
  • Literature Search & Review
  • Vigilance Quality Assurance
  • Signal Detection & Evaluation
  • Device Vigilance Reports Preparation & Submission
  • ADE and MDI Reconciliation
  • Field Safety Notices (FSNs)
  • Periodic reporting

We will contact you within one business day.