Medical Device Procurement Software for Qualification and Audit
Supplier qualification, controlled documentation, quality agreements and change approval as governed workflows.
It starts here
Component, device family, entity and supplier risk category are captured at the outset.
Proconomy runs
- TriggerThe supplier request records its intended use
- RuleQualification requirements are selected by risk category
- AgentEvidence is collected and validated
- HumanQuality, regulatory and procurement review in parallel
- HumanA quality agreement is executed
- RecordThe supplier is approved for a defined scope
What a request has to carry. Before anything can progress.
The supplier request records its intended use
What happens
Component, device family, entity and supplier risk category are captured at the outset.
Supplier qualification
You can configure qualification requirements by supplier category and risk, with explicit approval scope and named approvers.
Qualification requirements are selected by risk category
What happens
Documentation, quality agreement, audit and validation requirements are applied by rule.
Controlled documentation
Required document types, versions and validity tracked against the supplier, with expiry chased before it lapses.
Evidence is collected and validated
What happens
The supplier submits documentation through the portal; completeness, type and validity are checked and gaps chased.
Quality agreements
Agreements created from approved templates, connected to the supplier record and the purchases made under them.
The workflows this changes. Each one governed the same way.
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01
Supplier management
Qualification, document control and approval scope by supplier risk category.
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02
Contract lifecycle management
Quality agreements from approved templates with tracked obligations.
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03
Supplier quality management
Change control, audits and corrective action with human quality decisions.
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04
Security & AI governance
Approval authority, segregation of duties and complete audit trail.
Quality, regulatory and procurement review in parallel
What happens
Each function assesses the evidence within its own authority.
Every workflow above runs the same governed sequence. This is where it stops for a person.
See exactly where it runs. And exactly where it stops for you.
Qualifying a new supplier for a regulated component. A new supplier is proposed for a component used in a device family, requiring qualification before any purchase.
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Trigger
The supplier request records its intended use
Requirements are known before the supplier is contacted.
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Rule
Qualification requirements are selected by risk category
The right controls apply to the right supplier.
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Agent
Evidence is collected and validated
Less chasing, cleaner evidence.
-
Human
Quality, regulatory and procurement review in parallel
Faster qualification without collapsing accountability.
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Human
A quality agreement is executed
Obligations become tracked commitments.
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Record
The supplier is approved for a defined scope
Purchasing can proceed within a controlled boundary.
The supplier request records its intended use
Qualification requirements are selected by risk category
Evidence is collected and validated
Quality, regulatory and procurement review in parallel
A quality agreement is executed
The supplier is approved for a defined scope
Seen enough?
See a medical devices workflow of your own run end to end, with your supplier requirements applied.
Someone from client success replies, not a sales sequence. The assessment asks for no email.
Answer “who approved this, and why” in seconds. Not in weeks.
Routing agent
- Classify a request
- Permitted
- Request missing data
- Permitted
- Select buying route
- Permitted
- Approve above band
- Not permitted
Allowed actions
You list what each agent may do, and the most it can spend. You set both for every business unit.
Checkpoints that cannot be bypassed
Important decisions return to the people your policy names, and no configuration removes them.
Reconstructable
- Original request text
- Retained
- Rule that fired
- CAT-DRV-02
- Approvals and approvers
- Recorded
- Purchase order
- Written to ERP
You can pull the trail for any order, without reading a mailbox
Evidence without a separate tracker
Every action is attributed to an actor and the permission that allowed it, you can pull the trail for any order.
What stays with your people. Every one of these.
Decision 01
Qualification approval by quality, regulatory and procurement.
Decision 02
Acceptance of quality agreement deviations.
Decision 03
Assessment and approval of any supplier change.
Decision 04
Approval scope decisions covering components, device families and entities.
Where this already runs. In operations like yours.
- Industrial services and engineered products An industrial group unifies procurement across 18 operating companies 18 operating companies under one group 18 operating companiesOne group-level viewERP retained Read the story
- Automotive and mobility A global automotive manufacturer sees supplier risk beyond tier one Large, complex supplier network spanning tier one to tier N Tier 1 to tier N mappedOne supplier recordShared scorecards Read the story
Bring a real medical devices workflow. Not a vendor scenario.
One of your own processes, including the part that usually goes wrong. You will see where the agents act, where the platform stops, and what it leaves on the record.
Someone from client success replies, not a sales sequence. If we are not a fit we will say so on the first call.
Not ready to talk to anyone?
Fair enough. Both of these work without giving us your email.