Medical Device Vigilance
- Set up and maintenance of complete MDV system, for all types of devices
- Collection, investigation, and assessment of medical device incidents
- Submission of medical device incidents to Competent Authorities
- Storage and protection of medical device incidents records
- Preparation of Periodic Summary Reporting
- Preparation of Field Safety Corrective Action and the Field Safety Notice
- Writing and/or reviewing Standard Operating Procedures
- Audits/inspections and training on Medical Device Vigilance
- Writing and/or reviewing of Medical Device Vigilance Agreements