Helping You Establish And Maintain Risk Management File
I can help you establish and maintain a Risk Management File in compliance with your procedures and policies, and the following key standards and regulations:
- 21 CFR 820, Quality System Regulation
- ISO 13485, Medical Devices—Quality Management Systems Requirements
- ISO 14971, Application of Risk Management to Medical Devices
- ISO 9001, Quality Management Systems Requirements
- IEC 60601, General Requirements for Basic Safety and Essential Performance
- IEC 62304, Medical Device Software—Software Life-Cycle Processes
Here are the highlights of what I can do for your Risk Management File:
- Prepare and execute a Risk Management Plan that will describe the methodologies employed in risk management planning, analysis, evaluation, control, and reporting.
- Facilitate the Hazard Analysis process, including Design FMEA, Use FMEA and Process FMEA.
- Prepare and maintain Hazard Analysis Reports that will contain typical items, such as:
- Failure modes
- Failure effects
- Failure causes
- Probability of occurrence
- RPN number
- Risk mitigation
- Evaluation of residual risk—risk/benefit assessment
- Prepare a Risk Management Report that will document the risk management process, including a confirmation that all risks have been minimized as much as possible. Additionally, the Risk Management Report will establish and document a plan to collect, review, and evaluate information about the product or similar products in production and post-production phases.
To discuss how I can help your with Risk Management, contact me here.