Standard Training Service Plan for Medical Device Consulting Companies

1、 Service Overview
To assist medical device companies in efficiently responding to changes in industry regulations and improving their quality management level, our company has launched standardized training services that cover the entire process of regulatory interpretation, technical practice, and risk management, ensuring that enterprise teams quickly grasp core knowledge and reduce compliance risks.
2、 Service Content
In depth analysis of regulatory system
Comparison of Domestic and Foreign Regulations (China NMPA, EU MDR, US FDA)
Application Guide for the Latest Regulations on the Supervision and Administration of Medical Devices
Guidelines for Writing Registration Application Materials (including Template Cases)
Practical training on production quality management
Implementation of ISO 13485:2016 clauses
Key points for environmental control of sterile medical devices
Process validation and equipment calibration practical exercises
Risk Management Special Course
ISO 14971 Risk Management Full Process Simulation
Adverse event monitoring and recall case review
Prediction and Response Strategies for Common Issues in Flight Inspection

3、 Service advantages
Authoritative faculty: Former review experts+20 years of experience, dual mentorship system for corporate executives
Scenario based teaching: sand table simulation using real cases of FDA warning letters
Effect guarantee: Free Q&A for 3 months after training, accompanied by an online question bank to consolidate learning

4、 Implementation process
Requirement diagnosis (questionnaire+interview) → 2 Customized course plan → 3 Segmented training (theory+workshop) → 4 Effect evaluation (written test+practical assessment)

5、 Value added services
Gift the latest regulatory compilation electronic manual
Priority participation in industry summit quotas
20% discount on annual retraining

This plan can be flexibly adjusted according to the scale of the enterprise, supporting a mixed mode of online and offline, and helping enterprises build a compliant and efficient medical device professional team.