Risk Management for Medical Device

Proactively Identify, Evaluate, and Mitigate Risk

At PulseForward, we deliver expert-driven risk management services aligned with ISO 14971 and industry best practices. From early-phase hazard analysis to lifecycle post-market surveillance, we help medical device teams build risk-informed products that meet stringent global regulatory expectations. Whether you're launching a new product or updating a legacy system, our process ensures that safety and effectiveness are engineered from the ground up.

Our Risk Management Services Include:

• Preliminary Hazard Analysis (PHA): Rapid identification of potential hazards during early concept and system-level design.

• Risk Analysis & Evaluation: FMEA, FTA, and HAZOP tools tailored to your device type and intended use.

• Risk Control Planning: Development of mitigation strategies, design controls, and traceable documentation to reduce residual risk.

• Benefit-Risk Assessment: Structured justifications to demonstrate acceptability of risk in relation to clinical benefits.

• Lifecycle Risk Management: Integration of risk files with usability, cybersecurity, and post-market data per ISO/TR 24971 guidance.

• Regulatory Documentation Support: Creation or remediation of Risk Management Reports (RMRs) for FDA, EU MDR, or international submissions.

Why PulseForward?

Our cross-disciplinary team combines expertise in systems engineering, usability, cybersecurity, and quality management. This enables a holistic risk approach that aligns design intent with user needs, technical feasibility, and compliance expectations. We don’t just document risk—we help you understand it, reduce it, and defend your decisions in front of regulators.