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Supplier Management

Select, approve, manage and monitor suppliers in a single location.

Confident Supplier Selection

Pick the right product and service partners with a risk-based ISO 13485 §7.4 / FDA 21 CFR 820.50 compliant process.

Use structured, audit-ready data to document the supplier selection criteria, candidates, and evaluation evidence for your selection.

Streamline the approval process with an automated approval, notification and sign-offs.

Enhanced Supplier Transparency

Manage, categorize, and continuously assess all your suppliers centrally in a single location.

Get full visibility into your supply-base and track their performance.

Close the loop by connecting all supplier QM related processes, such as Supplies Audits, Nonconformity Assessments, Equipment and more.

Monitor and re-evaluate to ensure compliance

Products change. Suppliers change. Make sure suppliers still meet your standards with structured, risk-based re-evaluations.

Past performance does not guarantee future compliance. Never miss a supplier re-evaluation using auto reminders to the right person at the right time.

Demonstrate due diligence. Generate re-evaluation reports in seconds for audits or internal reviews.

Ready to get started?

Try the Aligned eQMS 30 days for free!


Genuine Voices, Tangible Results

We benefitted by being able to create risk analyses for various product groups quite quickly and easily. We could now focus more on the content, and leave the form to the system.

Andrea Paulus

Customer Service, Product & QM Support

Amazing to see how adaptable AE is to our development process and risk management process, giving us the ability to work swiftly without any unnecessary constraints!

Jaimin Patel

Regulatory Affairs Manager & Risk Manager

Aligned Elements supports a structured way to, starting from requirements, create a traceable set of documentation through the whole lifecycle.

Claes Nilsson

Master System Engineer

I can sincerely recommend Aligned Elements to any Medical Device company looking for a single tool to manage requirements, specifications, risks and design reviews.

Victor Steinacher

Project Manager

Aligned Element have made life easy working with requirement/verification including traceability. We could easily make a structure suitable for us, for all our different products and their specifications.

Anna Norlander

Senior Project Manager

Thanks to the Linked projects-feature, we are able to reduce the duplication of module documentation to a minimum.

Christoph Karthaus

R&D Manager

Quality Management capabilities for ISO 13485 compliance

Easy-to-use, secure and compliant document management.
Ensure and document employee competence. Demonstrate compliance at any time.
Change happens. Change drives you forward. You are prepared.
Feedback, Complaints, Nonconformities, CAPAs and Vigilance reporting.
Confidently demonstrate compliance with organized, traceable audit planning.
Track maintenance, calibrations, controls and repairs for all your important equipment.
Assess, control and manage CSV data for full compliance.