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Post-Market Surveillance
Post-Market Surveillance Overview
Pharma Wizardās post-market surveillance consultants help medical device manufacturers navigate the complexities of post-market surveillance regulations, including EU MDR post-market surveillance requirements and FDA medical device complaint handling.
Post-Market Surveillance Services
Products Complaints Management
End-to-end complaints management from intake to reporting and closure, ensuring efficient, effective, and timely closure of complaints as part of robust medical device PMS processes.
Device Recall & Return Management
Our team of experts will assist you in navigating complex regulations related to medical device recall and field safety actions, ensuring compliance, efficiency, and minimum disruption.
PMSP, PMSR, PMCF, PSUR, Annual Maintenance
Comprehensive support in creating, updating, and maintaining PMS documentation, including PMS Plans, PMS Reports, PMCF services, PSURs, and annual regulatory updates through expert post-market surveillance for medical devices.
Health Hazard Evaluation
We conduct scientific, evidence-based evaluations to assess the severity and probability of harm resulting from product issues, forming the basis for regulatory communication and decision-making around recalls or FSCA.
Medical Device Translation Service
Accurate, regulation-compliant translation of all PMS-related documentation including complaints, customer communication, FSNs, patient information, IFUs, labels, and regulatory reports delivered by native speakers with domain expertise.
Pharma wizard Medical Device Authorized Representative Services
Product Complaints Management
Device Recall, Corrections and Removals
PMSP, PMSR, PMCF, PSUR, Annual Maintenance
Health Hazard Evaluation
Medical Device Translation Services
Celebrating Customer Success
