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services overview

Fusionlife Solutions 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

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