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Medical Device Vigilance

Medical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Its primary purpose is to protect and improve safeguards for patients, users and others by preventing or reducing the likelihood of reoccurrence of incidents elsewhere.

Why MakroCare

Our expertise range from device clinical studies to the post-registration requirements. Our vigilance experts (Clinicians, Safety, and Case Reviewers) team is well experienced in handling 24×7 vigilance full-service activities for devices globally.

Our services

  • BulletProject management through consultancy on medical devices on Vigilance
  • Bullet Management of safety data based on the database of global safety
  • BulletProcessing, coding, follow-up, evaluation, and reconciliation of the Adverse Device Effect (ADE) and Medical Device Incident (MDI).
  • BulletPreparing and submitting the Device Vigilance Reports and MDR
  • BulletSafety Narrative writing & PSUR reports
  • Bullet Medical assessment along with detailed cases through literature review.
  • Bullet Generating and submitting Field Safety Corrective Action (FSCA) and even create Field Safety Notices (FSNs) for distribution.
  • Bullet Maintain and set up the MDV system for various device types.
  • BulletCollecting and assessing medical device incidents through investigation for submitting the reports to competent authorities.
The First Step

Let's talk about how MakroCare can help you