Evidence
Certifications and quality
alveofit devices are manufactured under a certified quality management system, with regulatory status stated separately for each product
Quality management
Manufacturing operates under ISO 13485, the international quality management standard for medical devices, and is audited under MDSAP — the Medical Device Single Audit Programme recognised by multiple regulators
Regulatory status
alveoair® holds US FDA 510(k) clearance and CDSCO approval for India. alveoflow® is CDSCO approved with a US FDA 510(k) submission pending. Clearance is always stated per product, never as a blanket claim across the range
Data protection
Patient data handling is aligned to HIPAA, GDPR and India's DPDP Act. Consent is explicit and revocable, and health information is encrypted in transit and at rest
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Imported from https://alveo.fit/certificate — needs an editorial pass before publication.