Bioana is officially ISO 13485 certified!
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The MedTech industry is moving toward more agile and resilient models, and nearshore manufacturing has become essential. In this context, Mexico—particularly Monterrey—stands out as a strategic destination thanks to its technical talent, regulated infrastructure, and proximity to the U.S.
Mexico offers specialized engineers, strong experience in design and validation, and a collaborative ecosystem that brings together universities, hospitals, and industrial centers. This enables faster development and reduces risks during Design Transfer.
The country offers capabilities aligned with global standards:
These elements ensure traceability and compliance for highly regulated medical devices.
Together, these advantages reduce time-to-market and strengthen product reliability.
Bioana brings engineering, cleanroom manufacturing, V&V, and low-volume production together under one roof—eliminating supplier fragmentation and enabling a faster, safer, and more traceable Design Transfer.
Mexico is ready to lead this shift. And Bioana is prepared to support companies looking to manufacture medical devices more quickly, seamlessly, and with full regulatory alignment.
“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”
Mark Lee
CEO, Ocumetics
"Our experience with Bioana had been outstanding. Their commitment, eye for detail, punctuality, proactivity and understanding manufacturing principles, workflow, quality and resourcefulness has been beyond our expectations."
Frank Harder
CRO , Bolb Inc.
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