Sigma Scientific
A medical device testing laboratory accredited under ISO/IEC 17025 and recognized by the FDA ASCA program. Half of the Hub’s value proposition.
Anchor Founding PartnerWho they are
Accredited testing and FDA regulatory experience
Sigma Scientific supports manufacturers with safety and performance testing, design verification and validation, and regulatory submissions to the FDA, including the 510(k), De Novo and PMA pathways.
ASCA is the FDA’s Accreditation Scheme for Conformity Assessment. Together with ISO/IEC 17025 accreditation, it means the laboratory’s testing follows recognized competence requirements and FDA-recognized standards.
Its role in the Hub
What Sigma Scientific brings to every project
Phase 3: Test
Safety and performance testing of the devices and technologies that come out of Hub projects.
Phase 4: Register
Support with the documentation for the applicable regulatory pathway.
Training and mobility
Visits and stays at its laboratory in Florida for students and faculty of partner universities.
Expert second opinion
Remote consulting for healthcare institutions: specification reviews before purchases and root cause analysis of incidents.
Aleph Innovation Challenge
Laboratory hours and mentoring as prizes for the best projects.
Governance
A permanent seat on the Hub’s Board of Directors.
One origin
The same founder, at the university and at the laboratory
Dr. Jorge Millán is the founder of Aleph University and the founder and Biomedical Director of Sigma Scientific. That shared origin is what allows a project born in the classroom to move straight into an accredited testing and regulatory validation environment.
References to the FDA, ISO/IEC 17025 and FDA ASCA describe the accreditation and services of Sigma Scientific. The Aleph Innovation Hub is not affiliated with or endorsed by the FDA. Testing services are provided by Sigma Scientific under its own terms.