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

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