ISO 14971 risk management: the file your regulatory dossier requires
We prepare the complete risk management file for your device under ISO 14971:2019, ready to be integrated into your dossier in any jurisdiction.
Risk management is no longer an annex
Every serious authority now requires a risk management file. And with the FDA QMSR in force, risk management became explicitly integrated throughout the entire quality system. It is not a document assembled at the end to tick a box: it is the backbone that supports product safety and the authority’s decision.
What the file includes
- Risk management plan.
- Identification of hazards and hazardous situations.
- Risk estimation and evaluation, with a matrix (for example 5×5).
- Control and mitigation measures, and verification of their effectiveness.
- Residual risk evaluation and benefit-risk analysis.
- Risk management report, ready to audit and integrate into the dossier.
Regulatory compliance
The file is prepared in accordance with ISO 14971:2019 and, for Argentina, the applicable ANMAT regulations (for example, Disposición 4/2015 for the products it applies to). The same base work serves, with the relevant adjustments, for ANVISA, FDA and CE files.
Frequently asked questions
What is the risk management file?
It is the set of documents that demonstrates you identified your device’s risks, evaluated them, controlled them and verified that the residual risk is acceptable against the benefit. Authorities request it as part of the dossier.
Is it mandatory to register with ANMAT?
For most products, yes. Risk management is a cross-cutting requirement in the jurisdictions we work with, with differences in form between them.
Does the same file work for ANVISA, FDA and CE?
The technical basis is the same; what changes is the format and some jurisdiction-specific requirements. That is why it pays to build it from the start with all target markets in mind.
How does it integrate with ISO 13485?
ISO 13485 requires risk management throughout the life cycle; ISO 14971 is the method for doing it. If we are implementing your QMS, the file integrates natively.
You may also need
ISO 13485 Quality Management System
Implementation of your audit-ready QMS, aligned with the FDA QMSR now in force.
View service ComplyMedical device registration and approval
Strategy and management of your device registration with ANMAT, ANVISA, FDA and CE, coordinated in a single base dossier.
View serviceDoes your dossier need a risk file?
Tell us about your product and we will build your risk management file.