Quick answers to common questions.
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Samples & Evaluations
We prioritize sample requests for qualified procurement entities to ensure rapid deployment and effective value analysis.
- Eligible: U.S. based hospitals, surgery centers, clinics, and Group Purchasing Organizations (GPOs).
- Verification: All requests are validated against NPI or facility license numbers before release.
Our staging hubs in Dallas and Phoenix allow for rapid turnaround to support immediate clinical evaluation needs:
- Validation: Requests are reviewed and approved within 24 hours.
- Transit: Once approved, standard ground shipping reaches most U.S. facilities in 2–4 business days via our domestic logistics network.
- Expedited: Overnight options are available for urgent clinical evaluations.
Every sample kit arrives as a "Committee-Ready" package designed to streamline clinical and value analysis reviews efficiently:
- Regulatory: FDA importer registration ID, device listing numbers, and 510(k) summaries (where applicable).
- Quality: ISO 13485 certificates and AAMI PB70 / ASTM test reports.
- Product: Full technical sheets, bilingual IFUs, and high-resolution packaging proofs.
Compliance & Quality
Yes. As the U.S. Importer of Record, Florence assumes regulatory accountability. We support hospital vendor credentialing and Joint Commission audits by providing:
- Historical lot traceability reports.
- On-demand sterile load records (release parameters).
- Direct access to our Quality Assurance leads for peer-to-peer review.
Compliance is continuous. Our digital document repository is updated in real-time to ensure survey readiness:
- Annual: ISO 13485 surveillance audits and FDA establishment registration renewals.
- Per Lot: Sterility and physical performance testing (tensile, barrier, linting) for every production run.
- Notification: You are proactively notified of any material change or certificate update 30 days in advance.
Yes. We power private label programs for several national distributors and health systems.
This includes custom packaging design, own-brand labeling (OBL) regulatory filing support, and dedicated inventory buffers to protect your brand equity.
Logistics & Supply
Our primary manufacturing hub is in Monterrey, Mexico, enabling nearshore agility and reduced carbon footprint:
- Bulk Freight: Direct truck delivery from Monterrey to U.S. distribution centers (Laredo crossing).
- Replenishment: Immediate shipping from Florence-managed 3PL hubs in Dallas, TX and Phoenix, AZ.
- Traceability: All shipments are fully tracked from factory floor to your dock via our logistics platform.
By producing in North America, we reduce transpacific volatility and shorten cash cycles:
- Stocked Items: 3–5 days (from U.S. warehouse).
- Made-to-Order Gowns/Masks: 10–14 days production + transit.
- Custom Packs: 18–28 days.
*Surge capacity agreements allow us to hold dedicated safety stock for your IDN.
Yes. We support EDI (850/855/856/810) and API integrations for automated procurement.
Our team works directly with your Lawson, Oracle, or Workday administrators to establish ASN (Advanced Shipping Notice) feeds and real-time inventory visibility.
Need something more specific?
Contact us and we’ll tailor documentation, samples, or a logistics session to your program.