Calculator
CE/FDA Compliance Checker
Check whether a vendor submission includes meaningful CE, MDR, FDA 510(k), FDA listing, model match, and certificate-validity evidence.
Calculator Inputs
Legend
CE/FDA Compliance Checker guidance
Readiness score = weighted compliance evidence score based on regulatory clearance, model match, certificate validity, and supplier authorization.
Input meaning
- Best regulatory evidence available: select the option that matches the source document, device label, certificate, or installed system.
- Model exactly matches offered device: enter the measured, quoted, or hospital-approved value in 0-100.
- Certificate validity/current status: enter the measured, quoted, or hospital-approved value in 0-100.
- Supplier authorization: enter the measured, quoted, or hospital-approved value in 0-100.
- Documents readable and complete: enter the measured, quoted, or hospital-approved value in 0-100.
Result interpretation
- Use the result as a planning estimate, not as a final approval by itself.
- Record the assumptions used so Procurement, Biomedical, Facilities, Finance, and vendors can review the same basis.
Assumptions
- This checker does not verify a certificate against a regulator or notified body database.
- High-risk equipment should be reviewed by biomedical, regulatory, and procurement teams before award.
Biomedical use
- Use this calculator during RFQ preparation, technical evaluation, acceptance planning, service review, or biomedical workload planning.
How to identify the required values
Use these examples and common working ranges to choose values from gauges, labels, manuals, datasheets, RFQs, service reports, CMMS records, or hospital planning assumptions.
| Field | Example value | Common range | Tip |
|---|---|---|---|
| Best regulatory evidence available | Example: FDA 510(k) or CE MDR certificate. | Select the option that matches the source document or installed system. | Use a site-specific value and document the source beside the result. |
| Model exactly matches offered device | Example: 100 0-100. | 80-100 means the certificate/model exactly matches the offered device and configuration. | Compare the exact model name on the certificate with the offered model. |
| Certificate validity/current status | Example: 100 0-100. | 80-100 means documents are current, traceable, and not expired. | Check expiry date and current certificate status. |
| Supplier authorization | Example: 100 0-100. | 80-100 means manufacturer or principal authorization clearly covers the bid scope. | Confirm authorization covers the supplier and equipment scope. |
| Documents readable and complete | Example: 100 0-100. | 80-100 means documents are readable, complete, and usable by procurement and biomedical reviewers. | Documents must be readable and complete enough for review. |
Common ranges are starting points for hospital planning. For final procurement, acceptance testing, electrical design, medical gas design, radiation shielding, dialysis water systems, or clinical use, replace the example values with site-specific data and vendor-confirmed figures.
Input Checklist
Confirm these values before relying on the output for procurement, PM, or service planning.
- Regulatory evidence type
- Model match
- Certificate validity
- Authorized supplier
- Document language
Safety And Engineering Notes
Use calculator outputs as planning estimates and verify critical systems with calibrated measurement or qualified engineering review.
- This checker does not verify a certificate against a regulator or notified body database.
- High-risk equipment should be reviewed by biomedical, regulatory, and procurement teams before award.
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