Demonstrate systematic risk management and regulatory compliance with this comprehensive Risk Management Report template.

Whether you're developing medical devices, software systems, or other regulated products, regulatory authorities and certification bodies demand rigorous evidence that you've systematically identified, analysed, evaluated, and controlled risks throughout the product lifecycle. This Risk Management Report gives your organisation a professional, ISO 14971:2019-compliant template for documenting your complete risk management process — from initial hazard identification through post-market surveillance — ensuring you can demonstrate to regulators, auditors, customers, and other stakeholders that your product meets acceptable safety thresholds while maintaining its intended performance characteristics.

The report template serves three critical functions that form the foundation of any compliant risk management program. First, it documents the systematic risk analysis performed on your product, capturing all identified hazards and evaluating the associated risks across every phase of the product lifecycle — from design and development through manufacturing, distribution, clinical or operational use, maintenance, and eventual product discontinuation. Second, it establishes the evidence requirements and verification activities necessary to demonstrate that risk controls are effective and that the product is safe for its intended use. Third, it defines the ongoing risk management processes and controls that will maintain product safety through post-market surveillance and continuous improvement activities.

The scope is comprehensive and lifecycle-oriented. The template addresses all identified hazards and associated risks across normal use conditions and reasonably foreseeable misuse scenarios. It integrates usability-related risks derived from human factors and use-related safety considerations, recognising that how people interact with products is often a critical source of risk. And it provides clear documentation of risk evaluation, risk control measures, residual risk assessment, and risk-benefit analysis — creating the complete evidence package needed to support regulatory submissions, certification audits, and ongoing compliance obligations.

For regulatory affairs professionals, quality managers, product development teams, and compliance officers, this report template is an essential documentation tool. It ensures consistency in how risk management activities are recorded and communicated. It satisfies the documentation requirements of ISO 14971, ISO 13485, ISO 27001, and other relevant standards. And it creates a clear audit trail showing that your organisation has exercised due diligence in identifying and controlling risks before products reach the market.

The template is fully customisable to your specific product type, risk management methodology, regulatory pathway, and organisational context.

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 | Pre-market submissions and certification audits