Regardless of the type of device, getting all the pieces together to bring a new medical device to market is challenging. Especially in the beginning when you would benefit the most from medical devices risk management using QMS software for medical devices, but can’t afford the typical QMS software price tag.
ISO 13485 medical devices quality management systems require some special features that are unique to the life science industry. Total Lean Management (TLM) has all the features needed for easy compliance to ISO 13485, ISO 14971, the MDSAP, FDA 21 CFR Part 11/820, ISO 31000 and ISO 14971 risk management for Medical Devices.
Whether it’s spinal screws or diagnostic tools, TLM medical device customers love the added bonus of our exclusive Upstream / Downstream dual technology user environment so that the quality professionals get to use a feature rich QMS for medical devices and everyone else has easy web app access to the key features they need to participate in the QMS software without being overwhelmed and confused by all the feature options of the main application.
Prototype to Production
TLM is hands down the best option for a small start up team to leverage their initial resources and build electronic compliance and risk management iso 13485 from the beginning without taking valuable resources away from R&D efforts. From concept, planning, design, validation, product launch, and post market surveillance, TLM has all the bases covered.
QMS Software for Medical Devices Checklist
- Medical device file type designations for DMR, DHF, DHR,RMF,and UEF.
- Linking capability between ISO 13485 and FDA requirements and the individual documents that address those requirements.
- Linking capability between internal audit requirements from ISO 13485.
- and FDA and the individual documents that address those requirements available from the internal audit checklist.
- Engineering Change Management.
- Bill of Materials linked to approved supplier management.
- Purchase Orders linked to approved suppliers. Customizable supplier approvals based on design stage.
- Separate redline drawing and documents can be attached to each revision.
- Upstream / Downstream user environment for easy adoption and quick deployment.
Single Source of Truth
Manage the entire life cycle of your device with an integrated framework that complies with FDA QSR and ISO 13485:2016 out of the box so that your medical device quality management system can help you define user needs and get your medical device to market faster, cost effectively, with less risk.
When the FDA says it’s time to audit your ISO 13485 medical devices quality management system, you will have the confidence from knowing the FDA has been auditing this software based QMS for more than 20 years.
Validation Documentation Included!
Don’t let other software try to convince you their software is “magically validated,” as the very definition depends on YOUR requirements you define and release in a test protocol prior to testing and validating any software that falls within the scope of ISO 13485, sect 4.1.6. TLM provides all our medical device customers access to our complete validation documentation set that includes a complete framework for documenting your validation efforts for both TLM and any other software that requires validation.
Existing customers can contact [email protected] for download access to the latest revisions of these test protocols.
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