Aleph University · Anchor Founding Partner: Sigma Scientific
From the classroom to the FDA, under one roof
A university licensed in Florida and a laboratory accredited under ISO/IEC 17025 and FDA ASCA, working together to take medical device and health technology innovation from idea to market.
About us
A health innovation ecosystem that joins a university and an accredited laboratory in one alliance.
The Aleph Innovation Hub is the strategic unit of Aleph University that brings together universities, healthcare institutions, industry, associations and government agencies to co-create knowledge, training and solutions in medical devices, regulatory science and health technology.
It was founded with Sigma Scientific as its Anchor Founding Partner: a medical device testing laboratory accredited under ISO/IEC 17025 and recognized by the FDA ASCA program. This alliance lets us take a project from the classroom to testing and regulatory validation, with no intermediaries.
Aleph University is a 100% online higher education institution based in Sunrise, Florida, licensed by the Commission for Independent Education (CIE) of the Florida Department of Education (License No. 12808) and a member of BioFlorida, the state’s leading life sciences network.
UNIVERSITY+
The problem
Today, bringing a medical device to market means knocking on three different doors.
A university to develop the talent.
Universities train engineers and scientists, often with no direct link to industry.
A laboratory to run the tests.
Testing laboratories operate far from academia and from early-stage projects.
A consultant to map the regulatory pathway.
Companies innovate without the regulatory support they need to reach the market on time.
Purpose
Our purpose
To build, through academic alliances and the ongoing participation of universities, healthcare institutions, public agencies and health and technology companies, a new ecosystem for innovation in health, technology and education, with social awareness and a global outlook, that drives sustainable professional, scientific and economic development for Latin America and the United States.
Within five years, to be the reference meeting point for universities, healthcare institutions, companies and public and private organizations in Latin America and the United States, recognized for driving applied research, joint training and knowledge transfer with measurable impact on employability, medical device and digital health innovation, and regional economic development.
How it works
Our own method: Detect, Validate, Test, Register.
Every project that enters the Hub follows the same four-phase route. In the last two phases, Sigma Scientific joins with accredited laboratory testing and regulatory support.
Detect
We identify real needs with healthcare institutions, companies and universities: clinical, technical or regulatory problems worth solving.
Validate
We assess the proposed solution against technical, clinical and regulatory criteria and define the route: which standard applies, which tests are needed and which regulator is involved.
Test
with Sigma ScientificThe device or technology undergoes safety and performance testing in a laboratory accredited under ISO/IEC 17025 and FDA ASCA, to FDA-recognized standards.
Register
with Sigma ScientificWe support the preparation of documentation for the applicable regulatory pathway (510(k), De Novo, PMA or the national regulator) and the route to market.
Areas of action
Six areas of work
Sectors
Who are you? See what the Hub offers your institution.
Universities and academic institutions
Real device testing for theses and projects, co-created programs, a regulatory credential for your students and mobility to an accredited laboratory in the United States.
See the benefitsHospitals, clinics and health networks
Continuing education for your clinical engineering staff, an expert second opinion on medical equipment and a role in applied research.
See the benefitsMedical device and health technology companies
A more direct path to the FDA: accredited testing, regulatory strategy and talent trained in science, regulation and technology.
See the benefitsRegulators, ministries and science agencies
Fee-free institutional cooperation to build technical capacity, move toward regulatory harmonization and connect innovation funding calls.
See the benefitsIndustry associations, chambers and clusters
Academic training and laboratory testing for your member companies. We join your network; we do not compete with it.
See the benefitsOur value proposition
A licensed university and a laboratory accredited under ISO/IEC 17025 and FDA ASCA, working as one unit. We develop the talent, test the device and open the regulatory pathway.
Six advantages in one place
A university and an accredited laboratory in one alliance.
Aleph University and Sigma Scientific share the same origin. A project born in the classroom goes straight to an accredited laboratory, with no intermediaries.
Our own method.
Detect, Validate, Test and Register: a clear four-phase route that is repeated and measured in every project.
Aleph-Sigma Regulatory Science Badge coming soon
A credential in development, backed by both a university licensed in Florida and an accredited laboratory, with an FDA module and modules for national regulators (Invima, Anvisa and Cofepris). About the credential
The regulatory bridge between Latin America and the United States.
We are the gateway for Latin American universities and companies that want to reach the FDA, with support in Spanish and technical backing in the United States.
Tangible benefits from the first project.
An initial test at a preferential rate for thesis projects, the annual Aleph Innovation Challenge with laboratory hours and mentoring as prizes, and mobility to Sigma Scientific’s laboratory in Florida.
Visible results, not just promises.
Every year we will publish a public impact report: projects supported, devices that advanced on their regulatory pathway and students connected with employers in the sector.
The scope and terms of each benefit (laboratory hours, preferential rates and length of mobility stays) are agreed with each member and set out in its agreement.
How we compare
Each model solves part of the problem. We bring the parts together for the same project.
We reviewed the main medical device innovation models in the United States and Latin America: industry clusters, university innovation labs and medtech accelerators.
| Capability | Industry clusters | University innovation labs | Medtech accelerators | Aleph Innovation Hub |
|---|---|---|---|---|
| Licensed graduate education | No | Yes | No | ✓ Yes |
| Testing laboratory accredited under ISO/IEC 17025 and FDA ASCA | No | No | Partial | ✓ Yes |
| Own regulatory credential | No | No | No | ✓ Yes |
| Regulatory bridge between Latin America and the FDA | No | No | No | ✓ Yes |
| Support from the classroom to regulatory validation | No | Partial | Partial | ✓ Yes |
Anchor Founding PartnerAnchor Founding Partner
Backed by an FDA ASCA accredited laboratory
Sigma Scientific is a medical device testing laboratory accredited under ISO/IEC 17025 and recognized by the FDA ASCA program (Accreditation Scheme for Conformity Assessment). It supports manufacturers with safety and performance testing, design verification and validation, and regulatory submissions to the FDA, including 510(k), De Novo and PMA.
Our creator
One origin: from science to the classroom, and from the classroom to the FDA
Dr. Jorge Millán is the founder of Aleph University and the founder and Biomedical Director of Sigma Scientific. He is a biomedical scientist with more than 25 years of experience supporting manufacturers with product development, engineering verification, regulatory compliance and FDA submissions. He holds a Ph.D. in Biomedical Engineering from the University of Miami and an M.S. in Electrical Engineering from the University of Pennsylvania, and he has authored more than 25 scientific publications.
This dual role, founder of both a university and an accredited laboratory, is what makes the Hub possible: a single origin connects academic training with the regulatory validation of medical devices.
Two markets
One proposition designed for two markets
United States
A proven model. The university-plus-laboratory approach already works at leading U.S. institutions. We take it further.
What sets us apart. Our own credential, a four-phase method and a natural bridge to Latin American talent and markets.
A statewide ecosystem. We are members of BioFlorida, Florida’s leading life sciences network.
Latin America
An open space. There are strong clusters and good academic programs, but we have not found a model that brings a university and an accredited laboratory under one roof.
A market on the move. Medical devices are already Costa Rica’s leading export (about 43% in 2024, according to PROCOMER), Mexico leads the sector’s exports to the region (ECLAC), and Colombia’s Invima is part of the IMDRF.
We add, we don’t compete. We partner with national clusters and associations to provide the training and testing they currently lack.
Initial focus: Colombia, Mexico and Costa Rica.
What we will achieve
What we will achieve together
- A formal network of partner universities, healthcare institutions and companies, linked by agreement.
- Joint applied research projects in medical devices, digital health and regulatory affairs.
- Co-created training programs: courses, certificates and bootcamps developed by Aleph, partner universities and companies.
- Training connected to real verification testing and regulatory validation.
- Internships, employability and mentoring for students and graduates in the sector.
- Incubation of projects with spin-off or technology transfer potential.
- Published knowledge: articles, technical reports and conferences.
Identity, founding charter and founding alliance with Sigma Scientific.
Agreements signed with the first members, formation of the Board of Directors and a launch event.
First joint projects, new members and publication of the first results report.
Membership
Join the Aleph Innovation Hub
Membership is formalized through a Memorandum of Understanding (MOU), the appointment of an institutional coordinator and participation in at least one project or initiative per year.
Fill out the interest form.
We schedule a meeting to get to know your institution.
Together we define the category and scope of your participation.
We sign the agreement and start the first project.
News and resources
Hub news
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Frequently asked questions
Questions before you decide
What is the Aleph Innovation Hub?
It is the strategic unit of Aleph University that brings together universities, healthcare institutions, companies, industry associations and government in an innovation ecosystem for medical devices, regulatory science and health technology, with Sigma Scientific as its Anchor Founding Partner.
Who can join?
Universities and academic institutions, hospitals and clinics, healthcare and technology companies, and industry associations or clusters. Government entities take part through an institutional cooperation agreement.
Is there a membership fee?
Terms depend on the membership category and the scope of participation, and they are set out in the agreement. For government entities, cooperation is fee-free.
What does it mean that Sigma Scientific is the Anchor Founding Partner?
It means the Hub has, from day one, a laboratory accredited under ISO/IEC 17025 and recognized by FDA ASCA that carries out the testing and regulatory support for its projects.
Do I need to be in the United States to take part?
No. The Hub works online and in Spanish with institutions across Latin America, and it serves as a bridge to the U.S. regulatory system.
I am a professional or a student. Can I take part?
Yes, through your institution if it is a member, or directly through Aleph University programs and the Aleph Innovation Challenge. Write to us and we will point you to the best route.
How are agreements signed?
After an initial meeting, both parties sign a Memorandum of Understanding (MOU) that sets out the category, the commitments and the benefits for each side.
What happens after I submit the form?
Our team will contact you within 5 business days to schedule a first meeting.
Others connect companies. Others develop talent. Others test devices.
We do all three, for the same project, from day one.
Send your membership application or book a 30-minute meeting with our team. We reply within 5 business days.
Prefer to talk first? Book a meeting →