Your most direct path to the FDA
Accredited testing, regulatory strategy and prepared talent, in one ecosystem.
- Evidence accepted for 510(k), De Novo and PMA
- Comparative regulatory strategy
- Preferred access to prepared talent
The challenge
Reaching the market means coordinating too many providers.
Manufacturers, distributors and startups innovate, but reaching the market requires accredited testing, a clear regulatory pathway and staff who speak the language of science, regulation and technology. Coordinating all of that across different providers takes time and money.
Your company finds accredited testing, a regulatory pathway and prepared talent in one place. The Hub gains real market challenges and opportunities for its students.
Benefits for your institution
What your institution gets
Accredited testing and validation
Sigma Scientific's laboratory, accredited under ISO/IEC 17025 and FDA ASCA, testing to FDA-recognized standards.
Comparative regulatory strategy
Support to comply with your national regulator and also reach the FDA.
Prepared talent
Preferred access to students and graduates of Aleph and partner universities.
Training for your teams
Preferential rates on Hub programs, courses and certificates.
Open innovation
Joint projects with universities and sponsorship of the Aleph Innovation Challenge.
For technical training academies
A continuity route for your graduates toward the Aleph-Sigma credential (coming soon) and Sigma Scientific's laboratory.
Visibility
Co-branding in Hub publications, events and materials.
For your employees and students
- Updates on FDA and local regulation, quality and risk management.
- Access to the Aleph-Sigma credential, once available, as a next professional step.
- Exposure to real testing processes and regulatory strategy.
What you bring to the ecosystem
- Real product and market challenges.
- Industry experience for student training.
- Internships and job opportunities.
- Your network of clients and institutions, which extends the ecosystem's reach.
Corporate Partner
Requirements: a Memorandum of Understanding (MOU), a designated coordinator and participation in at least one project, event or initiative per year.