ISO 14971

The requirements for medical devices, including the Medical Device Directive (93/42/EEC), the In-Vitro Diagnostics Directive (98/79/EC) and the Active Implantable Medical Device Directive (90/385/EEC), detail requirements for risk management.

ISO 14971 harmonises global regulations for risk management. This means meeting the requirements of the standard can help you to demonstrate compliance.

Our software helps you manage risks, identify issues and get more data from your management systems.

Complex circle

Medical device risk management best practice.

Be confident in your approach.

Confidence you're following best practice

Easy-to-manage speed and cost to get your medical devices to market.

Systematically identify risks

Manage foreseeable hazards, customer complaints and create vigilance reports.

Streamline the regulatory process

Associate documentation, risks, issues and training records in a central system.

Evaluate risk classes

Document likelihood and severity and manage associated issues, workflows and escalation paths.

Mitigate risks

Assign responsibility and ownership for risks in production, IFU and training.

Integrate with other standards

Associate risks with standards such as ISO 13485 to reduce duplication of effort.

Life science businesses across the globe rely on our software and services

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Pharma compliance management software
Biotech quality management software
pharmaceutical quality management software
York instruments medical devices quality management software solution
Biocair logistics medical supply business
Monosol quality management system ISO 9001
Medical device manufacturers ISO 13485 DYSIS
NHS document control management software
Sodexo ISO 55000 software
Indivior medical device compliance
Cardiome quality and training record management software

Integrated modules for ISO 14971

Modules work well on their own or in harmony together.
Audit management software
Audit management software
Too many businesses hope that when an external auditor is examining their business they don’t uncover any issues. But this approach causes stress, encourages a reactive culture and exposes the business to high levels of risk. A regular and thorough internal auditing programme helps you identify an...
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Supplier management software
Supplier management software
Qualsys's supplier compliance management software provides you with all the controls you need to treat external providers as an extension of your business. Deliver unshakeable governance, risk and compliance controls, understand supply chain risks, and extend quality best practice to your suppliers....
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Accident & incident management software
Accident & incident management software
When an accident or incident occurs, it's important there is an accurate record of events to understand the root cause and prevent it from happening again. Use our accident and incident management software to properly record, communicate and identify trends to prevent it from happening again.
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Equipment maintenance software
Equipment maintenance software
Over 70% of organisations have no formal method for managing how equipment is used, maintained and eventually replaced, or for ensuring there’s a qualified person on-site to operate that equipment. Managing business equipment correctly is crucial if your organisation is to compete in the fast-pace...
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Document control software
Document control software
Modern technology means we are bombarded with information. The challenge is making sure the right information is viewed by the right person at the right time. Document Manager by Qualsys provides a comprehensive and powerful solution for the distribution and control of all types of crucial documenta...
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Medical device datasheet

This datasheet explains how medical device companies can use each of Qualsys’s software modules to comply with Standards such as ISO 13485 and ISO 14971.

Validation brochure

Learn how Qualsys helps you plan validation, implement an efficient validation process and re-validate when there is a change to your processes and systems.

See a live ISO 14971 management system in action. Request a demonstration of our software here:

ISO 13485:2016 clauses and how our software helps you comply
Organisations who design, develop, produce, or install medical device products or services often make a strategic decision to certify to ISO 13485:2016. ISO 13485 harmonises medical device regulatory requirements and provides a best practice framework for a medical device quality management system....
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