Hospital wound care procurement teams don’t just buy a dressing—they buy the vendor’s ability to stay compliant, traceable, and interruption-free for the life of a contract.
This checklist is designed to be auditable. Each checkpoint includes (1) what to ask for, and (2) how procurement can verify it without relying on marketing language.
Pro Tip: Treat “compliance” as a pack of controlled documents (with revision control), not a single certificate.
How to use this checklist
Use Phase A to screen suppliers before you invest time in samples and pricing.
Use Phase B to validate documentation before award (or before adding a product to formulary).
Use Phase C to monitor compliance after award (change control is where many contracts fail).
What counts as a “compliance pack” for silicone foam dressings
A procurement-ready compliance pack typically includes:
Quality system evidence (e.g., ISO 13485 certificate + scope)
Regulatory and traceability evidence (FDA registration/listing where applicable; UDI/GTIN readiness)
Safety evidence (biocompatibility evaluation, and sterility validation when supplied sterile)
Change-control commitments (notification timelines; documented impact assessment)
The goal is not to “collect PDFs.” It’s to confirm the supplier can support traceability, audit readiness, and controlled change across manufacturing, packaging, labeling, and distribution.
Procurement compliance checkpoints (organized by phase)
Phase A — Pre‑RFP supplier screening (fast pass/fail)
1) ISO 13485 quality system is current and scope‑appropriate
Ask for: ISO 13485 certificate + certification body + scope statement.
Verify: Certificate is in-date; scope covers the activities you’re buying (e.g., manufacturing and/or sterile packaging if applicable).
Pass if: Certificate is current and scope aligns to the dressing’s lifecycle.
2) FDA establishment registration + device listing can be evidenced (US)
Ask for: FDA registration/listing evidence and the entity/role (manufacturer, specification developer, initial importer).
Verify: Confirm they understand FDA establishment registration/device listing obligations (and update cadence). In US contexts, this is governed by 21 CFR Part 807 establishment registration and device listing.
Pass if: They can provide consistent establishment details and a clean explanation of who is the “labeler” vs manufacturer.
3) UDI is present on labels and packages (US)
Ask for: Packaging artwork (unit + shipper), label samples, and UDI format details.
Verify: The regulatory baseline is that device labels and packages bear a UDI under 21 CFR 801.20 (eCFR).
Pass if: They can show UDI placement consistently across packaging configurations.
4) UDI data integrity plan exists (DI/PI, GUDID readiness)
Ask for: A UDI assignment policy naming the issuing agency, plus a UDI mapping table.
Verify: Ensure they can distinguish DI vs PI and keep them consistent across systems. The UDI system definitions (DI/PI concepts) are laid out in 21 CFR Part 830 (eCFR).
Pass if: They can produce a mapping table showing DI/PI elements across label, item master, and any public database records where relevant.
5) Sterility claims are supported (only if the product is supplied sterile)
Ask for: Sterilization method (EtO vs radiation), sterilization validation summary, and routine monitoring approach.
Verify: Validation is typically aligned to standards such as ISO 11135 (ethylene oxide sterilization) or ISO 11137-1 (radiation sterilization).
Pass if: They can provide validation evidence and explain ongoing control (not just “it’s sterile”).
Phase B — Pre‑award diligence (audit‑ready validation)
6) Biocompatibility evaluation is risk‑based and documented (ISO 10993)
Ask for: Biocompatibility evaluation report (or summary) and materials/contact classification rationale.
Verify: FDA guidance recognizes ISO 10993-1 as a framework for biological evaluation within a risk management process—see FDA guidance on ISO 10993-1 biocompatibility evaluation (2023).
Pass if: They provide a clear evaluation path tied to device contact type/duration and material changes.
7) Documentation is controlled (document control + revision history)
Ask for: Document index, revision history, and document control procedure summary.
Verify: Look for consistent revision identifiers across:
IFU / labeling
packaging artwork
sterilization documents (if sterile)
material specs
Pass if: They can show controlled versions and retrieval within 24–48 hours.
8) Change notification is contractual and specific
Ask for: Change notification policy + examples of “major vs minor” change classification.
Verify: Policy covers at minimum changes to materials, adhesives, packaging, label format, sterilization site/process, and critical suppliers.
Pass if: They commit to a notice period (e.g., 60–180 days depending on change type) and provide an impact assessment package.
9) UDI/GTIN verification can be tested with a sampling plan
Ask for: A SKU list with DI/GTIN, label images, and a way to spot-check records.
Verify: Perform a small sampling test:
Match DI on label to your item master fields.
Confirm PI elements (lot/expiry) are scannable/capturable in receiving.
Confirm barcode quality verification exists (verifier reports; re-verification cadence).
10) EU MDR readiness (if you source for EU/UK or want MDR-level documentation discipline)
Ask for: CE certificate details (where applicable), EU QMS certificate, Declaration of Conformity, and a statement of technical documentation availability.
Verify: Your goal is not to read the entire technical file—it’s to confirm the supplier can provide the required MDR-era documentation promptly during audits and incidents.
Pass if: They can provide a structured document set and a clear owner for regulatory correspondence.
⚠️ Warning: “We are registered” is not the same as “we are approved.” For US device contexts, establishment registration/listing supports FDA oversight but does not itself imply FDA clearance/approval—build your diligence around the specific documentation and traceability you need.
Phase C — Post‑award monitoring (keep compliance from drifting)
11) Quarterly KPI pack is defined (supply + quality)
Ask for: A monthly/quarterly scorecard including definitions.
Verify: Require consistent calculation rules for:
OTIF (on-time in-full)
line-item fill rate
backorder notification timing
complaint handling lead times
Pass if: KPIs are measurable, reported on time, and tied to escalation steps.
12) Complaint, recall, and field action response is testable
Ask for: Complaint handling procedure summary + recall/field action playbook + named contacts.
Verify: Ensure they can provide batch traceability and rapid document retrieval.
Pass if: They can support time-bound responses and root-cause/CAPA summaries when needed.
13) Annual compliance refresh is scheduled (not reactive)
Ask for: Annual refresh cadence for certificates, sterilization validations (as applicable), and label/UDI mapping.
Verify: Tie renewals to your contract calendar and formulary review.
Pass if: The supplier agrees to proactive refresh submissions.
Vendor‑agnostic compliance pack request template (copy/paste)
Subject: Request for silicone foam dressing compliance pack (procurement due diligence)
Hello [Supplier Team],
We are conducting procurement due diligence for silicone foam dressings. Please provide a compliance pack covering the SKUs in the attached list.
1) Quality system
ISO 13485 certificate (including scope and certification body)
Document control overview (how you manage revisions for labeling/IFU/artwork)
2) US regulatory + traceability (for US distribution)
FDA establishment registration and device listing evidence (identify your role: manufacturer/specification developer/initial importer)
UDI assignment policy (including issuing agency) and a UDI mapping table for the requested SKUs:
Device Identifier (DI) / GTIN (if GS1)
Production Identifier (PI) elements used (lot/expiry/serial/manufacture date)
How DI/PI map to your item master and shipping labels
3) Labeling & barcode verification
Unit + shipper packaging label artwork (showing UDI placement)
Barcode verifier reports (most recent) and re-verification cadence
Confirmation that HRI matches encoded barcode data
4) Safety evidence
Biocompatibility evaluation summary aligned to ISO 10993-1 (or equivalent rationale)
5) Sterility (only if supplied sterile)
Sterilization method and validation summary (e.g., EtO per ISO 11135 or radiation per ISO 11137)
Routine monitoring/release approach (high level)
6) Change control & post-market
Change notification policy, including notice periods and what triggers a customer notification
Complaint handling contact details and typical response SLAs
Please include:
A document index with revision/date for each file
The owner/contact for regulatory documentation questions
Thank you, [Name] [Title / Value Analysis / Supply Chain] [Hospital / IDN] [Email / Phone]
Example: how to keep brand mentions compliant (without vendor bias)
If you need to mention a supplier in internal discussions, keep the framing factual and neutral:
“We requested a compliance pack from a manufacturer like SLK Medical and validated UDI/GTIN mapping, ISO 13485 scope, and change notification commitments.”
That sentence describes a process you can replicate with any vendor, without implying comparative superiority.
FAQ (procurement-focused)
Do we need both UDI and GTIN?
In practice, many hospital systems rely on GS1 GTIN as the supply chain identifier and UDI as the regulatory identifier structure. Your goal is data integrity: the identifier on-pack should match the identifier in your item master and (where applicable) any public records.
What’s the fastest “trust but verify” test for a new supplier?
Run a SKU sampling audit: pick 5–10 SKUs, match label DI to your ERP/MMIS item master, confirm PI elements (lot/expiry) are scannable, and confirm UDI requirements are understood per the eCFR references.
Where should UDI requirements be documented?
In the US, UDI labeling requirements are codified in the eCFR. Start with the rule text in 21 CFR 801.20 and the system definitions in 21 CFR Part 830.
Next steps
Copy the template above into your RFP workflow, then add a simple sampling plan (SKUs, evidence required, pass/fail criteria). If you want a starting point for internal procedures, you can also review this supplier evaluation checklist from SLK Medical and adapt it to your hospital’s governance model.
