ISO 14971 serves as a guiding light for medical device manufacturers, outlining the principles and processes necessary for identifying, evaluating, and controlling risks associated with medical devices. Compliance with ISO 14971 ensures that your device’s risk management practices align with international standards, promoting safety, quality, and regulatory approval.
Tento+’s Role in ISO 14971 Compliance
Tento+ offers a comprehensive suite of features that simplifies the journey toward ISO 14971 compliance. Here’s how this tool can become your invaluable asset in this endeavor:
- Risk Management Framework: Tento+ provides a structured risk management framework aligned with ISO 14971, guiding users through risk assessment, evaluation, and control activities.
- Risk Identification: Utilize Tento+ to systematically identify and document potential hazards and associated risks for your medical device.
- Risk Assessment: Tento+ aids in evaluating the severity, occurrence, and detectability of identified risks, facilitating the determination of acceptable risk levels.
- Risk Control: Implement risk mitigation measures efficiently with Tento+, ensuring that risks are reduced to an acceptable level and documented for traceability.
- Traceability: Achieving traceability between risk management activities and other aspects of your device development is a key requirement of ISO 14971. Tento+ offers visual traceability features to connect risk elements with design outputs and specifications.
- Documentation and Reporting: Tento+ streamlines the documentation process by automating the creation of risk management reports and ensuring they align with ISO 14971 requirements.
On top of these, you’ll also need SOPs that describe how your team works and how they handle software problems, deployment, and source management. If you are looking for hands on advice, head to our programmes page, and we will get you Compliant in 4 Weeks.