QMS & Global Regulatory ServicesRisk management is a systematic process of identifying potential hazards, analysing and evaluating associated risks, implementing appropriate risk control measures, and monitoring their effectiveness throughout the product lifecycle.
Effective risk management helps medical device/IVDs organizations to address safety concerns, support regulatory compliance, and ensure that risks associated with medical devices/IVDS are evaluated and controlled in accordance with ISO 14971.
Medreg will assist medical device/IVDs organizations in developing and maintaining comprehensive Risk Management of Medical Device is in accordance with ISO 14971. Product risks are typically considered during the design and development phase of the product lifecycle and updated as the post-market surveillance of the device.
Product Risk Management File includes
- Risk Management Policy
- Risk Management Plan
- Hazard Identification
- Risk Analysis
- Risk control measures and benefit-risk analysis
- Risk Management Reports
Risk-Based Approach to QMS Implementation
In addition to product-specific risk management, Medreg support medical device organizations to apply a risk-based approach to implement their Medical Device Quality Management System (MDQMS). It involves identifying and evaluating risks associated with QMS processes and determining appropriate controls based on their potential impact on product quality, safety, regulatory compliance, and process effectiveness.
