BioStem is dedicated to the relentless pursuit of healing through our commitment to innovation and quality.
Since 2014, BioStem Technologies, Inc. has been a leading biomedical innovator, trusted by clinicians across specialties to deliver best-in-class solutions for advanced Surgical Care and advanced Wound Care. We’re passionate about boldly advancing innovation while upholding the principles of good stewardship that have led to us to where we are today, delivering high quality placental allograft products that inspire confidence in our clinicians and partners and help patients improve their lives.
OUR STATE-OF-THE-ART, VERTICALLY INTEGRATED MANUFACTURING FACILITY ENSURES THE HIGHEST LEVELS OF QUALITY:
- 6,100 sq. ft. dedicated area
- 3,000 sq. ft. ISO clean room space
- Located in Pompano Beach, FL
AATB accredited | cGTP facility
Tissue Regulation
Quality Statement
At BioStem Life Sciences, we hold ourselves to the highest standards of quality because there is nothing more important to us than the trust of our customers and the safety of their patients. In our AATB accredited, FDA registered, cGMP compliant lab, we provide products and services which not only meet but exceed, Current Good Tissue Practice requirements.
Tissue Regulation
The products offered by BioStem Technologies are perinatal tissue-derived allografts. They are regulated as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P) by the U.S. Food and Drug Administration (FDA), are minimally manipulated, and are produced in accordance with the FDA regulations for Good Tissue Practices (21 CFR 1271).
Association for Advancing Tissue and Biologics Accredited
The American Association of Tissue Banks is the organization that sets standards, inspects facilities, and accredits tissue banks in North America.
Certificates and Licenses
AATB Accreditation
BioStem Life Sciences Expires: March 12, 2029
FDA Registration
BioStem Technologies Expires: January 1, 2027
BioStem Life Sciences Expires: January 1, 2027
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