Software intensive systems are an increasingly vital part of health care delivery both with respect to the
management and distribution of patient data and the life critical real-time operation of complex medical
devices. Standards such as ISO 14971 guide medical device companies in addressing the challenge of
balancing residual risks with the anticipated benefits of using an innovative technology to treat patients.
CSL has provided safety expertise and helped attain regulatory approval of client’s innovative technologies.
Typical client needs
- Hazard analysis and risk assessment
- Process improvement
- Independent safety assessment of products
- Validation and verification
- Compliance with safety standards
- Training on risk management
Click here to contact us.