How We Vet

The MEDRIXX
Standard.

Regenerative and cosmetic biologics have moved faster than regulation, and marketing has too often outrun the evidence. Before MEDRIXX represents a manufacturing partner to a practice, that partner has to clear a standard — not a sales pitch.

Sourcing & Donor Eligibility

Represented tissue-based partners must document exactly where material comes from and how each donor was cleared, before we bring a product to a practice.

✓Tissue accepted only from full-term, live-birth C-section donors

✓Sourced exclusively through AABB-accredited U.S. cord banks

✓Donors screened across a full infectious-disease panel — HIV, Hepatitis B & C, HTLV, syphilis, CMV, Zika, West Nile virus, and Chagas disease

✓Documentation maintained in line with FDA Section 361 and 21 CFR Part 1271

Manufacturing & Environment

We favor partners who treat manufacturing as engineering, not craft — controlled, documented, and repeatable from one lot to the next.

✓Manufactured exclusively in FDA-registered U.S. facilities

✓Produced in classified cleanroom environments with validated air, pressure, and particulate monitoring

✓Protocol-driven production designed for batch-to-batch consistency

✓Full chain-of-custody traceability from source tissue to finished lot

Testing & Release

A product doesn't ship on a partner's word. Independent, third-party data has to back every claim before it reaches a practice.

✓Every batch tested by an independent lab for USP <71> sterility and USP <85> endotoxin levels

✓Exosome-based products characterized by independent particle (DLS) and proteomic (mass-spectrometry) analysis

✓Results reviewed against applicable FDA release criteria before a lot ships

✓Lot-level certificates of analysis available to represented practices on request

Education & Support

Documentation only helps if a practice can actually use it. We translate it, and we stay reachable after the first order.

✓Plain-language technical briefings, not marketing decks

✓Practice-level protocol and workflow support

✓Direct, independent representation — not a call center

✓Ongoing access to regulatory and documentation updates

Private Consultation

Let’s talk
practice.

Tell us what your practice is exploring. A MEDRIXX representative will follow up with relevant professional information.

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