Supplier Management
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.
Genuine Voices, Tangible Results
Genuine Voices, Tangible Results
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
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
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
Thanks to the Linked projects-feature, we are able to reduce the duplication of module documentation to a minimum.
Christoph Karthaus
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
Aligned Elements supports a structured way to, starting from requirements, create a traceable set of documentation through the whole lifecycle.