Medical devices: how it works and what to require
Medical device procurement depends on qualified suppliers, controlled documentation and change approval that can be evidenced. Proconomy governs supplier qualification, quality agreements, document control and supplier change workflows, with human approval at every consequential point and the evidence retained against the supplier and the purchase.
Your QMS is not the problem. Everything around it is.
The procurement work feeding it is where the elapsed time goes.
Supplier qualification
- Qualification scoped to a device family
- Evidence gathered across quality, regulatory and finance
- Site audit scheduling and outcome
- Requalification on a defined cycle
- Approval scope enforced at purchase
- Qualification file retrievable on request
Quality agreements
- Agreement created from an approved template
- Notification obligations with owners
- Review dates that do not pass unnoticed
- Obligations connected to the supplier record
- Change-notification clauses enforced
- Agreement position visible at award
Change control
- Supplier process change requiring assessment
- Material or component substitution
- Site or equipment relocation
- Sub-supplier change
- Retrospective assessment after a late notice
- Re-qualification triggered by a change
Audit readiness
- Qualification files assembled as work happens
- Decision history per supplier and component
- Document currency across the supply base
- Corrective action history
- Evidence for a notified body request
- Retention to your policy
What the platform does here
| Mechanism | What it has to do |
|---|---|
| Device-family-scoped approval | Clearance for one product line never silently becomes clearance for another. Scope is explicit and enforced at the point of purchase. |
| Parallel qualification review | Quality, regulatory and finance review the same evidence set concurrently rather than sequentially, which is where most of the elapsed time goes. |
| Quality agreement obligations tracked | Notification clauses, review dates and obligations carry owners and surface before the date rather than during an audit. |
| Change notification assessment | A supplier change reaches procurement, quality and regulatory for assessment before it takes effect. |
| Evidence assembled as work happens | The qualification file is built during the process rather than reconstructed from three mailboxes when requested. |
| Retention to your obligation | Configured to the longest applicable requirement rather than a product default. |
A description of what the practice requires, not a feature list.
What to make any vendor demonstrate
- Request a supplier qualification file as a notified body would, and time it.
- Attempt a purchase for a device family the supplier is not approved for.
- Show quality, regulatory and finance reviewing the same evidence concurrently.
- Ask what happens when a quality agreement review date passes unactioned.
- Ask precisely where the boundary sits between this and your QMS.
Definitions. Asked and answered.
No. Proconomy supports configurable workflows associated with supplier qualification, documentation, quality agreements and change control. Compliance and certification remain the responsibility of your organisation and its auditors.
No. Your quality management system remains the formal quality record. Proconomy governs the supplier and procurement workflows around it and retains the procurement-side evidence.
As configurable requirements with type, version and validity tracked against the supplier record, collected through the portal and chased before expiry. Adequacy judgements remain with your quality reviewers.
The notification opens a governed assessment routed to quality, regulatory and procurement. Acceptance, conditions and any re-qualification requirement are human decisions that are recorded.
The evidence is produced as the work happens — approvals, applied rules, documents and decisions retained per supplier and purchase — so preparation becomes retrieval rather than reconstruction.
Yes. Approval scope is explicit and covers specified components, device families and entities. It does not extend by default.
ISO 13485 is the quality management system standard for medical devices, covering design, production, installation and servicing. It certifies the organisation's quality system; software used within that system is not itself certified.
A supplier quality agreement is a formal document defining quality responsibilities between a device manufacturer and a supplier, typically covering specifications, change notification, non-conformance handling, records and audit rights. Its value depends on whether its obligations are actually tracked.
The EU Medical Device Regulation governs the placing of medical devices on the European market, with requirements covering clinical evidence, post-market surveillance and traceability through the supply chain. Supplier control and documentation are a substantial part of the obligation.
No. Proconomy does not make an organisation compliant and is not a quality management system. It governs the procurement work around one and keeps the evidence current as that work happens.