Regulatory pathway · all topics

ISO 14971:2019 Risk Management for Medical Devices

ISO 14971:2019 is the central risk management standard for medical devices. Defines a process across the entire product lifecycle: risk analysis, risk evaluation, risk control, residual risk evaluation, risk management report, and post-production information. Required for compliance with FDA QSR design controls (820.30) and EU MDR Annex I General Safety and Performance Requirements. ISO/TR 24971:2020 provides guidance on application. Hazard analysis must address normal use, foreseeable misuse, and intended use environment.

Source

ISO 14971:2019 'Medical devices - Application of risk management to medical devices'

https://www.iso.org/standard/72704.html

How MedTek OS handles this

Compass drafts the iso 14971:2019 risk management for medical devices workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

Try the sandbox Ask the agent about this

Related pathways

510(k) Premarket Notification

A 510(k) clearance under 21 CFR Part 807 Subpart E demonstrates substantial equivalence to a legally marketed predicate device. Required for...

De Novo Classification Request

De Novo creates a new classification for a novel low-to-moderate risk device with no valid predicate. Submission under 21 CFR Part 860 Subpa...

Premarket Approval (PMA)

PMA is the most stringent FDA pathway, required for Class III devices that support or sustain human life or pose significant risk. Filed und...

Investigational Device Exemption (IDE)

An IDE under 21 CFR Part 812 allows an unapproved device to be used in a clinical study to gather safety and effectiveness data. Required wh...