Supplier Performance Management for Medical Device Manufacturers | EvaluationsHub
Medical Device Manufacturing

Supplier performance management for medical device manufacturers

Qualify, score, and monitor every critical and non-critical supplier in one place. Built for the supplier quality, regulatory, and procurement teams who carry ISO 13485, FDA 21 CFR 820, and EU MDR pressure, and who cannot let a supplier nonconformity become a field action.

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ISO 27001 certified GDPR compliant Hosted in the EU
VP
Vantage Precision
Contract manufacturer · Critical supplier
7.6/10
Overall score
Incoming quality
8.8
Regulatory compliance
9.2
CAPA responsiveness
5.4
On-time delivery
7.1
Change control
6.8
ISO 13485 valid CAPA overdue 12 days Re-qualification due Q3
CAPA overdueescalated to SQE lead
Trusted by 350 B2B teams worldwide
★★★★★ 4.9/5 on G2
The reality behind every submission

Your suppliers are inside your design history file. Your tools were never built to manage them.

Most medical device teams run supplier performance across spreadsheets, an approved supplier list nobody re-qualifies on time, and a CAPA log that is separate from the scores that should have triggered it.

The approved supplier list lives in a spreadsheet
Supplier qualification records, risk classifications, and re-qualification dates sit in a static file. When an auditor asks to see your current ASL with evidence, you scramble to assemble it from three systems.
CAPAs are open longer than anyone admits
A nonconformity triggers a CAPA, containment happens, and then root cause and effectiveness verification drift. The same finding returns in the next Notified Body or FDA audit.
Supplier changes happen without you knowing
A contract manufacturer changes a sub-component, a process step, or a raw material source. You find out during incoming inspection, or worse, from a complaint in the field.
Scores and CAPAs live in different systems
Supplier performance data is in one place, CAPAs in another, and certificates in a third. No single view connects a declining score to the action it should have triggered.
Your QMS handles procedures. EvaluationsHub handles supplier performance.
Built for supplier quality, regulatory, and procurement

One place to qualify suppliers, close CAPAs, and stay audit-ready

One supplier score your Notified Body can stand behind
Multi-stakeholder scorecards combine incoming quality, regulatory compliance, CAPA responsiveness, delivery, and change control into a single rating that SQE, regulatory, and procurement all trust. Each supplier segment gets its own metrics and weightings, so a contract manufacturer is not scored the same way as a raw material supplier.
Certificates and qualifications in one controlled place
Suppliers upload ISO 13485 certificates, biocompatibility reports, sterilization validations, and insurance through their own portal. You see what is current, expiring, or missing at a glance, instead of reassembling the ASL before every audit.
Nonconformities become CAPAs that actually close
Turn a supplier nonconformity into a tracked corrective and preventive action with an owner, a deadline, and containment-to-effectiveness status. Nothing closes until the evidence is in and effectiveness is verified.
Auto-flagging with Eva AI · coming soon
See risk before it becomes a field action
Risk monitoring surfaces suppliers whose quality or responsiveness is declining, so you intervene on the trend instead of reacting to a complaint, a lot hold, or a field safety corrective action.
Reviews that hold suppliers accountable
Structured reviews put you and your supplier in front of the same scores, the same CAPA history, and the same open-action list. Re-qualification decisions are backed by data, not gut feel.
One audit trail for every score, CAPA, and certificate
Every rating, qualification record, and corrective action is timestamped with role-based access. When a Notified Body, FDA inspector, or MDSAP auditor asks for evidence, it is already assembled.
How it works

From a declining supplier to a closed CAPA

1
Score
Rate every supplier across incoming quality, regulatory compliance, CAPA responsiveness, delivery, and change control using templates your team defines per supplier segment.
2
Flag
Declining scores, overdue CAPAs, and expiring certificates are surfaced for review, so nothing drifts out of sight.
3
Act
Open a corrective and preventive action with an owner and a deadline in one click. Track from containment through root cause to effectiveness verification.
4
Close
Evidence goes in, effectiveness is verified, the action closes, and the full trail stays ready for your next audit.

A supplier nonconformity never costs you just the lot

A single slip can mean a lot hold, a complaint investigation, or a field safety corrective action. By then it is your CE marking, your 510(k), your Notified Body relationship, and your patients on the line. Supplier performance management exists to catch the trend long before it reaches that point.

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Works with your stack

Connects through native Salesforce sync, a REST API and webhooks, CSV and Excel import and export, and AWS AppFlow for 40+ enterprise services. No rip and replace of your QMS or ERP required.

Enterprise-grade, and your data stays in Europe

Your supplier, CAPA, and qualification data is sensitive. It is protected accordingly and hosted in the EU.

ISO 27001 Certified GDPR Compliant AWS EU · Paris region 4.9/5 on G2 Trusted since 2021

See it on your own suppliers

Book a 30-minute demo and we will map EvaluationsHub to your ISO 13485 supplier programme, using your real approved supplier list and CAPA workflow.

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