Global PharmaTek 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