Establish a systematic, lifecycle-based approach to risk management with this comprehensive Risk Management Plan template.

Regulatory authorities don't just want to see that you've identified and controlled risks after the fact — they want evidence that you had a deliberate, structured plan in place from the beginning. This Risk Management Plan gives your organisation an ISO 14971 and ISO 13485-compliant template for defining the risk management activities, deliverables, responsibilities, and criteria that will govern how you identify hazards, estimate and evaluate risks, implement controls, and monitor effectiveness throughout the entire lifecycle of your medical device, software system, or regulated product. It's the foundational document that demonstrates to regulators, auditors, and certification bodies that risk management isn't an afterthought but an integrated, systematic process embedded in your design and development activities.

The plan establishes the complete framework your organisation needs to manage risk proactively and consistently. It defines the risk management process that will be followed, identifies the hazards associated with your device or product, sets out the methodology for estimating and evaluating risks, establishes the individual and overall risk acceptance criteria that will guide decision-making, assigns clear responsibilities for risk management activities, and defines how the effectiveness of risk controls will be monitored over time. This comprehensive structure ensures that everyone involved in the product lifecycle — from design engineers to quality managers to regulatory affairs specialists — understands their role in identifying and controlling risks.

Critically, the plan also establishes that risk management is not a one-time activity but a continuous process. It provides for regular reviews and updates during different stages of design and development, ensuring that the risk management approach evolves as the product matures, new information becomes available, or the regulatory landscape changes. This lifecycle perspective is essential for maintaining compliance with ISO 13485, demonstrating due diligence to regulators, and ensuring that post-market surveillance findings feed back into ongoing risk management activities.

For regulatory affairs professionals, quality managers, project managers, and product development teams, this plan template is an essential governance document. It satisfies the requirement in ISO 14971 for a documented risk management plan. It provides the framework for conducting risk management activities consistently across projects and product lines. And it creates the foundation for all subsequent risk management deliverables — including risk analyses, risk management reports, and post-market surveillance activities.

The template is fully customisable to your specific device or product type, development methodology, risk management process, and organisational structure.

Suitable for: Medical device manufacturers, software developers, and regulated product industries | ISO 14971, ISO 13485, FDA QMSR, MDSAP & ISO 27001 compliance | Regulatory affairs, quality assurance, and product development teams | Design control and lifecycle risk management