Description
Every step of the product development process must adhere to stringent standards to protect both consumers and your brand’s reputation. At the heart of this endeavor lies effective risk management – a systematic approach to identifying, assessing, and mitigating potential risks associated with medical devices. Our comprehensive package of documents has been meticulously curated to support you in this crucial aspect of product development, while ensuring strict adherence to regulatory standards such as ISO 14971 and ISO 24971.
Central to our package is the Risk Management Procedure (P02), a foundational document that outlines the systematic approach to identifying, evaluating, and controlling risks throughout the product lifecycle.
Complementing the Risk Management Procedure are a suite of essential templates designed to streamline and standardize your risk management processes. The Risk Management Plan Template (F02_1) provides a structured framework for documenting risk management activities, including risk assessment criteria, risk acceptance criteria, and risk mitigation strategies. This template ensures alignment with ISO 14971 requirements, facilitating compliance and enhancing the robustness of your risk management efforts.
Additionally, our package includes the Risk Management Report Template (F02_2), which enables you to effectively communicate the outcomes of your risk management activities, including identified hazards, risk assessments, and mitigation measures.
Furthermore, our package features templates such as the Hazard Analysis Template (F02_3), Risk Analysis Template (F02_4), and Traceability Matrix Template (F02_5), which provide structured frameworks for conducting comprehensive hazard and risk assessments, as well as ensuring traceability between risks, mitigations, and design inputs.
This package contains the following documents:
- Risk Management Procedure
- Risk Management Plan Template
- Risk Management Report Template
- Hazard Analysis Template
- Risk Analysis Template
- Traceability Matrix Template
