Manage your ISO 13485 compliance
This guide highlights how Ideagen solutions can help medical device organizations meet the specific requirements of ISO 13485.
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What is ISO 13485 and why is it important?
Ensure that safety and quality is prioritized at every stage of the medical device life cycle with ISO 13485 compliance. Achieving ISO compliance is a challenging journey but can be simplified by integrating the right quality management system.
Ideagen solutions is trusted worldwide with helping medical device organizations achieve accreditation, learn more about this in the guide.
GUIDE OVERVIEW
Ideagen solutions for ISO 13485
This guide highlights how Ideagen solutions modules can help medical device organizations meet the specific requirements of ISO 13485. Here are a few of the modules:
Learn how Ideagen solutions can help you achieve and maintain ISO 13485 accreditation with ease.
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Audit
Verify policies and procedures through regular internal audit and demonstrate compliance of systems with requirements.
Non-conformities
Capture and analyze incidents, discrepancies and complaints in real-time. Create action plans and track through to completion.
Documents
Define and document the scope of your system, policies and procedures, all with robust document control. Secure, central storage for instant access, even across multiple sites.
Equipment
Track and monitor calibration, maintenance and safety tests to achieve a higher standard of equipment control.
Training
Maintain and improve competence with a flexible framework. The module allows you to monitor and analyze staff training and development.
Suppliers
Monitor and evaluate the performance of suppliers, including equipment and consumables, to ensure quality of service.
Learn how Ideagen solutions can help you achieve and maintain ISO 13485 accreditation with ease.
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Fresenius Kabi
Leading healthcare company Fresenius Kabi Ltd have successfully worked with Ideagen solutions to reduce staff workload, improve the management of corrective and preventive actions (CAPA), and to get better control over their documents.
They removed their paper-based processes and implemented an electronic quality management solution to meet the requirements laid down by key regulatory bodies. Among a range of other certifications, they use Ideagen solutions to help maintain their ISO 13485 compliance, in what is a tricky regulatory environment on the European continent.
Ideagen solutions has allowed us to look at ways and areas where we can continually improve, developing the business. It allows us to keep our customers satisfied with our services while maintaining the levels of quality they have come to expect.
Access the guide
Download our free Ideagen Quality Management guide for ISO 13485:2016 - Medical Devices and learn how you can achieve accreditation.
"Excellent quality management tool"
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"Excellent quality management tool"