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ISO 14971 software

ISO 14971 software

Manage medical device risks with Lumiform, ensure compliance, reduce hazards, and streamline risk management processes.

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Trusted by enterprises with proactive frontline teams and the highest standards

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Streamline medical risk management

Medical device companies using Lumiform reduce hazards, improve compliance, and accelerate risk assessments.

33%

faster risk assessments with dynamic templates and automated workflows.

40%

reduced safety incidents with proactive monitoring and real-time updates.

35%

improved compliance rates with automated audit trails and scheduled reminders.

The value Lumiform brings to ISO 14971 medical risk management

Learn how Lumiform ensures medical device safety, simplifies compliance, and accelerates risk management.

Ensure device safety

Mitigate risks effectively with real-time updates and proactive monitoring tools.
Ensure device safety

Simplify compliance

Stay compliant with ISO 14971 through automated logs and scheduled reminders.
Simplify compliance

Accelerate assessments

Perform risk assessments faster with dynamic templates and automated workflows.
Accelerate assessments
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Discover the impact of advanced risk management

Explore how medical device companies ensure safety, reduce risks, and improve compliance with our ISO 14971 software.

ISO 14971 software

Leverage our ISO 14971 software to transform medical device safety and compliance.
Explore the Lumiform product
ISO 14971 software

95% of companies that implement Lumiform increase their frontline teams' productivity, health, and safety

High performer Europe 2024High performer emea 2024High Performer small businessHigh performer spring 2024Fastest implementationEasiest to use

Start managing medical device risks with a free ISO 14971 template from Lumiform.

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  • ISO 14001 internal audit checklist template
  • MDSAP audit checklist template
  • MDSAP vs ISO 13485 checklist
View all templates

We provide you with all resources you need

Access a comprehensive suite of resources designed to simplify medical risk management, from guides to real-world use cases.

ISO 13485: A guide to quality management in medical devices
Topic guide

ISO 13485: A guide to quality management in medical devices

By Inioluwa Ademuwagun
December 17th, 2024
•
10 min read
Navigating medical device regulations: Key steps for compliance 
Topic guide

Navigating medical device regulations: Key steps for compliance 

By Inioluwa Ademuwagun
October 28th, 2024
•
10 min read
A beginner's guide to MDSAP audits
Topic guide

A beginner's guide to MDSAP audits

By Inioluwa Ademuwagun
November 17th, 2024
•
13 min read
A beginner’s guide HIPAA polices and procedures
Topic guide

A beginner’s guide HIPAA polices and procedures

By Inioluwa Ademuwagun
October 29th, 2024
•
9 min read
4 free ISO 13485 audit checklists for medical devices
Template collection

4 free ISO 13485 audit checklists for medical devices

By Inioluwa Ademuwagun
December 17th, 2024
•
4 min read
4 free MDSAP audit checklist templates 
Template collection

4 free MDSAP audit checklist templates 

By Inioluwa Ademuwagun
November 17th, 2024
•
5 min read
12 best HIPAA forms for proper compliance
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12 best HIPAA forms for proper compliance

By Inioluwa Ademuwagun
October 29th, 2024
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7 min read
13 free GMP audit checklists to improve compliance
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13 free GMP audit checklists to improve compliance

By Ima Ocon
December 20th, 2024
•
8 min read
How to perform safety inspections
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How to perform safety inspections

By Max Elias
December 8th, 2023
•
1 min read
10 clauses of ISO 9001
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10 clauses of ISO 9001

By Max Elias
May 23rd, 2023
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1 min read
ISO 45001 at a glance
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ISO 45001 at a glance

By Oti Francis
March 16th, 2025
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0 min read
5 ways workflow automation streamlines healthcare administration
Journal

5 ways workflow automation streamlines healthcare administration

By Max Elias
March 11th, 2024
•
7 min read

Everything you need to boost productivity, safety, and quality.

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Other solutions that could interest you

Discover how companies in various industries can benefit from using Lumiform for ISO 14971 software.

Use cases

Check out how the Lumiform software can be utilized for related use cases.

Healthcare risk management softwareSafety Management SoftwareISO 15189 softwareISO software
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Frequently asked questions

How does Lumiform support ISO 14971 compliance?

Lumiform provides a centralized platform to digitize and streamline your risk management process. From identifying hazards to tracking mitigation measures, Lumiform ensures compliance by automating workflows, generating real-time insights, and maintaining a complete audit trail all in one easy-to-use tool.

Can Lumiform handle complex risk assessments?

Yes! Lumiform’s risk matrix tool allows you to map out and prioritize risks visually, making it simple to tackle even the most complex assessments. You can customize forms, assign tasks, and track progress in real time, ensuring nothing is missing.

Is Lumiform suitable for teams of all sizes?

Absolutely. Lumiform is designed to scale with your needs, whether you’re a small team or a large organization. Its intuitive interface and customizable features make it easy to onboard your team, collaborate effectively, and maintain compliance without hassle.

Revolutionize your ISO 14971 risk management with Lumiform

Managing risk under ISO 14971 demands precision, consistency, and control. Lumiform transforms how you approach risk management by digitizing and streamlining every step of the process. 

Whether you’re conducting a risk assessment for a medical device or tracking mitigation measures, Lumiform provides the tools to simplify compliance. Imagine easily assigning tasks to your team during a risk evaluation or generating a full report with just a few clicks. 

With our ISO 14971 software, you can reduce errors, improve collaboration, and ensure nothing is overlooked. 

Streamline your ISO 14971 compliance 

Staying compliant with ISO 14971 doesn’t have to feel overwhelming. Lumiform gives you a smarter, simpler way to manage risk assessments from start to finish. Whether you’re identifying potential hazards or following up on mitigation actions, everything is trackable in real-time so nothing slips through the cracks.

Instead of getting bogged down with repetitive admin, automated workflows take care of things like assigning tasks or scheduling reviews. And with built-in analytics, you can quickly spot trends, catch issues early—like a design flaw during a medical device review—and assign corrective actions on the spot.

Lumiform helps your team stay aligned, reduce risk, and move faster while staying fully compliant every step of the way.

This ISO 14971 software also equips you with the tools to meet ISO 14971 requirements efficiently and effectively. From prioritizing risks to ensuring traceability, every feature is helpful in supporting your compliance journey. 

  • Risk matrix tool: Visualize and prioritize risks to focus on what matters most. 
  • Automated audit trail: Maintain transparency and traceability for audits and regulatory reviews. 
  • Centralized document management: Securely store and access all compliance-related documents in one place. 

Use Lumiform for your ISO 14971 compliance success

Implementing Lumiform for your ISO 14971 compliance is straightforward and efficient. Start by customizing digital forms and checklists to align with your risk management processes. 

Onboard your team by assigning roles and providing access to Lumiform’s intuitive interface, which requires minimal training. Use the platform to set up automated workflows for tasks like scheduling risk assessments or tracking corrective actions. 

Best practices include leveraging real-time tracking to monitor progress and using Lumiform’s analytics to identify trends and improve decision-making. Regularly review and update your risk matrix to ensure it reflects the latest data and compliance requirements. 

Your compliance process can become streamlined, transparent, and easy to manage with this software.

Take control of your compliance today

Ready to simplify your ISO 14971 compliance? Start your free trial with Lumiform and experience how our software transforms your risk management process. Customize forms, streamline workflows, and ensure audit readiness.  

Related categories

  • Risk and compliance
  • Healthcare
  • ISO

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