RiskWise Medical Services
Comprehensive Risk Management Support
Partnered Risk Management Solutions – We collaborate with medical device companies through contract-based training and support, ensuring seamless integration of ISO 14971
Design Control Services
- Flexible Engagement Models Whether as an outsourced partner or an extension of your internal team, we adapt to your needs.
- Full or Partial Design Control Support – From initial design planning to verification & validation (V&V) and design transfer.
- Regulatory Compliance & Documentation – We create and maintain Design History Files (DHF) and Risk Management Files (RMF) in accordance with ISO 14971 and FDA 21 CFR Part 820.
- Seamless Integration – We work alongside R&D, Quality, and Regulatory Affairs to ensure compliance without slowing innovation.
- Gap Analysis & Remediation – We assess existing documentation and processes, identifying gaps and implementing corrective actions.
Risk Management Training
- Learn how to implement ISO 14971 and FDA risk management guidelines to ensure compliance in medical device development.
- Hazard Analysis & Mitigation – Master techniques like FMEA and risk-benefit assessment
- Regulatory & Quality Integration – Understand how to align risk management processes with design control, post-market surveillance, and regulatory submissions