Aleph-Sigma Regulatory Science Badge
A regulatory science credential in development, backed at the same time by a university licensed in Florida and a laboratory accredited under ISO/IEC 17025 and FDA ASCA.
- Backed by a university and an accredited laboratory
- FDA module
- Modules by national regulator
Structure
One FDA module, plus modules by national regulator
The credential is designed for people who work with medical devices in Latin America and need to understand both their own regulator and the FDA.
FDA module
The U.S. regulatory framework for medical devices, including the 510(k), De Novo and PMA pathways.
Invima module
Requirements of Colombia’s national regulator.
Anvisa module
Requirements of Brazil’s national regulator.
Cofepris module
Requirements of Mexico’s national regulator.
Who it is for
- Students and graduates of partner universities.
- Clinical engineering and technical staff at healthcare institutions.
- Professionals at medical device and health technology companies.
- Graduates of technical training academies in electromedicine and clinical engineering.
Why it is different
- Dual backing: a licensed university and an accredited testing laboratory.
- Connected to real verification testing, not only to coursework.
- Built around the regulators of the region, with a bridge to the FDA.
The credential is in development. Format, requirements, duration and recognition will be published at launch.
Be the first to know when it opens
Institutions can also express interest in offering the credential to their students or staff.