Smarteeva Post Market Surveillance

Highlights

• Smarteeva helped medical device companies build a competitive advantage through Next-gen solutions of automation and artificial intelligence. This has enhanced customer satisfaction, product quality, and regulatory compliance.
• COMPLAINTS MANAGEMENT SYSTEM 👉 Smart Data Collection Techniques 👉 High-end Complaint Management decision trees 👉 Compliant with regulatory authorities such as the FDA, EU, PMDA, and TGA 👉 NexGen Artificial Intelligence
• FIELD NOTIFICATION MANAGEMENT 👉 Notice creation and assignment 👉 Customized Intuitive feedback forms 👉 On-time notification management
• ADVERSE EVENTS MANAGEMENT 👉 Advanced Decision Tree 👉 Auto populating common data 👉 Cutting–edge Data Management System
• MDREngine 👉 Clean and enhance data from MDRs (MAUDE) with Warning Letters, Recalls, Product Registrations and FAERS 👉 Automatically and Continually refreshed Adverse Events, Warning Letters, Recalls and Clinical Studies data
• REGULATORY COMPLIANCE 👉 ISO 27001 👉 21 CFR Part 11/EU Annex 11 (ERES)