ISO 14971 Risk Management Process Compliance Testing
The ISO 14971:2016 standard defines a process for managing risks associated with medical devices. Compliance with this international standard is essential for manufacturers, ensuring that the benefits of the device outweigh its potential risks. This service provides comprehensive testing and certification to ensure compliance with all aspects of the ISO 14971 risk management process.
The ISO 14971 standard requires a structured approach to identifying, analyzing, evaluating, controlling, and monitoring risks associated with medical devices. Our testing aligns with this framework by ensuring that each phase is thoroughly addressed:
- Identification of the intended purposes and intended uses
- Identification of all relevant risks
- Risk analysis including risk estimation and risk evaluation
- Decisions on whether further actions are necessary to control or eliminate identified risks
- Implementation of measures to control or eliminate identified risks
- Ongoing monitoring and review of the risk management file and its associated records
The process encompasses a series of steps that must be meticulously followed, from initial hazard identification to post-market surveillance. Our laboratory ensures that every stage is rigorously tested according to ISO 14971 guidelines.
Our services include:
- Pre-clinical and clinical data analysis
- Risk assessment documentation review
- Device risk analysis using real-world scenarios
- Validation of control measures effectiveness
- Evaluation of post-market surveillance reports
- Continuous improvement recommendations based on testing outcomes
By providing these services, we ensure that medical devices meet stringent safety and efficacy standards set by regulatory bodies worldwide. This not only enhances patient safety but also supports the manufacturer's compliance with international regulations.
| Applied Standards | Description |
|---|---|
| ISO 14971:2016 | The international standard that defines a process for managing risks associated with medical devices. This includes hazard identification, risk estimation, and control measures. |
| IEC 60601-2-2 | A subset of IEC standards focusing on electromagnetic compatibility (EMC) requirements for medical electrical equipment. Ensures that the device does not interfere with other electronic devices in a clinical setting. |
Applied Standards
| Standard | Description |
|---|---|
| ISO 14971:2016 | The international standard that defines a process for managing risks associated with medical devices. This includes hazard identification, risk estimation, and control measures. |
| IEC 60601-2-2 | A subset of IEC standards focusing on electromagnetic compatibility (EMC) requirements for medical electrical equipment. Ensures that the device does not interfere with other electronic devices in a clinical setting. |
Quality and Reliability Assurance
- Our testing facilities are equipped with state-of-the-art instrumentation to ensure accurate measurement of risk parameters.
- We employ highly qualified personnel who are experts in medical device safety and regulatory compliance.
- All test results are reviewed by a panel of industry-leading specialists for accuracy and consistency.
- Continuous quality improvement programs are in place to ensure our processes meet the highest standards.
The reliability and accuracy of our testing directly impact your product's success. By ensuring that every aspect of ISO 14971 is meticulously followed, we provide you with peace of mind knowing that your devices are compliant with international standards.
Customer Impact and Satisfaction
- We understand the importance of timely compliance testing. Our streamlined processes ensure that you receive results within agreed timelines.
- Your satisfaction is our priority. We provide detailed reports with actionable insights to help you improve your products further.
- Our dedicated customer service team ensures that any questions or concerns are addressed promptly and effectively.
Customer impact and satisfaction are integral to our service delivery model. By providing reliable, accurate, and timely results, we ensure that your medical devices meet the highest safety standards and regulatory requirements.
