ISO 14971 Risk Management for Medical Devices

CLEIO integrates ISO 14971 risk management into every stage of the medical device development lifecycle, from early hazard analysis through validation and regulatory submission.

ISO 14971 Risk Management Consulting for Medical Device

CLEIO provides ISO 14971 risk management consulting for medical devices, bringing together mechanical, electronic, firmware, software, human factors, and systems engineering expertise within a single ISO 13485-certified organization. This integrated structure ensures that risk identification, evaluation, and control are coordinated across every discipline throughout the product lifecycle.
For over 20 years, our multidisciplinary team has managed risk across complex, regulated medical device programs, aligning hazard analysis, risk controls, and documentation with FDA, Health Canada, EU MDR, and international regulatory standards.

How We Apply ISO 14971 Risk Management Across Medical Device Development

CLEIO supports risk management for medical devices across every stage of the development lifecycle. We apply a structured process in full alignment with ISO 14971, delivering a traceable and audit-ready approach from planning to final report.

Risk Management Planning

Our team defines the scope, responsibilities, risk acceptability criteria, and the overall risk management plan for the specific device and its intended use.

Risk Analysis

We identify intended use, reasonably foreseeable misuse, hazards, and hazardous situations to estimate the probability and severity of potential harms associated with the device.

Risk Evaluation

Our experts compare estimated risks against defined acceptability criteria to determine which risks require further control measures before development proceeds.

Risk Control

We implement and verify mitigation measures following the ISO 14971 hierarchy: inherently safe design, protective measures, and safety information provided to the user.

Risk Management Report

Our team produces a comprehensive residual risk evaluation, confirms that the risk management plan has been followed, and documents that the overall residual risk is acceptable.

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What Activities Does ISO 14971 Risk Management Consulting Include?

At CLEIO, risk management is embedded within each discipline through a unified framework that ensures risks are identified early, controlled effectively, and fully documented. We cover every activity with a compliant approach aligned with ISO 14971, ready for regulatory review.

Hazard Identification & Risk Analysis

We identify potential hazards across hardware, software, and user interactions, then estimate risks based on severity and probability of harm.

Risk Acceptability Criteria Definition

Our team establishes clear, documented criteria for risk acceptability aligned with ISO 14971 requirements and applicable regulatory standards.

Risk Control & Mitigation

We design and implement effective risk control measures following the ISO 14971 hierarchy, and verify their effectiveness through testing and analysis.

Use-Related Risk Management

Our team applies human factors engineering methods to identify use-related hazards, analyze user interactions, and mitigate potential use errors throughout the product lifecycle.

Risk Traceability & Documentation

We build and maintain a complete, compliant risk management file, including the risk management plan, risk analysis, risk evaluation, and final report, ready for FDA or international regulatory submission.

Cross-Disciplinary Integration

Our team coordinates risk management procedures across design, mechanical, electronic, software, and systems engineering to ensure consistency and comprehensive system coverage.
CERTIFICATIONS

Quality and Compliance at Every Stage of Development

CLEIO applies an integrated quality management system built on internationally recognized medical device standards. From concept through market launch, our multidisciplinary teams collaborate within a controlled ISO framework to ensure all development activities meet quality assurance best practices.
ISO 13485 certification ensures that all regulatory and development work is guided by audited, structured processes that support consistent service quality and reliable outcomes. Products are developed in accordance with applicable harmonized standards to meet medical device regulatory requirements, accelerating time to market and supporting approval by relevant authorities.

ISO 13485:2016

Quality Management System

ISO 14971:2019

IEC 62304:2006 / AMD1:2015

IEC 60601-1 Ed. 3.2

IEC 62366-1:2015 / AMD1:2020

PROJECTS

Medtech Projects Showcase

Smart Patient Monitoring System with Companion App

We designed and engineered an innovative home-use patient monitoring sensor to track incontinence.

Console for Calcified Artery Disease Treatment

We have collaborated with Soundbite Medical to design and develop the latest commercial version of their medical device.

Ophthalmology Device with Software Driven by AI

Development of an ophthalmology diagnostic tool using offline image analysis software driven by artificial intelligence (AI).
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WHY CLEIO

Why Teams Choose CLEIO

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