In medical devices, managing risk is not about ticking boxes. It is about protecting patients, and with them your brand and your product.
Compliance Management Solutions helps you identify hazards, evaluate their impact and implement controls across the device lifecycle, following ISO 14971, FDA, MDR and TGA requirements. The outcome is audit ready, defensible risk documentation.
Risk assessment services
- Product risk analysis and documentation
- Design, usability and process FMEA
- Risk control verification and validation
- Regulatory and post-market risk evaluation
Hands-on risk training, 2.5 days
We also run an interactive 2.5 day risk assessment training programme. Participants learn the ISO 14971 principles, apply practical techniques and work through case studies with consultants who do this work in practice.
The combination matters. Consulting produces the risk file. Training means your team can maintain and defend it after we leave.
To discuss risk management support or to register interest in the training programme, please contact our regulatory team.