medical device risk analysis

Job ID: 36687852

Budget: ₹100 – ₹400 INR

I am in need of a freelancer who can provide documentation for a medical device that falls under Class I classification. The project requires a risk analysis method using Failure Modes and Effects Analysis (FMEA). Has previous regulatory experience with medical device. Education background in pharmacy or medical.

Key requirements:
- Experience in medical device documentation and risk analysis methods (ISO:14971)
- Expertise in FMEA analysis .
- Knowledge of Class I medical devices and associated regulations

The freelancer will be responsible for:
- Conducting a thorough risk analysis using FMEA method
- Creating a comprehensive documentation for the medical device
- Ensuring compliance with Class I medical device regulations

The ideal candidate will have:
- Proven experience in medical device documentation and risk analysis methods
- Strong understanding of FMEA analysis
- In-depth knowledge of Class I medical devices and associated regulations
- Attention to detail and ability to work independently

If you believe you have the required skills and experience, please apply for this project.