BIS · Medical device management system
IS 23485:2019 · Licence and scope schedule reviewed
What this means for your family
A documented software lifecycle makes quality responsibilities and the scope of developmental-support modules easier to examine.
- Licence number
- MD/L-2026029599
- Issuer
- Bureau of Indian Standards
- Licence holder
- Bharath Healthcare Laboratories Private Limited
- Stated validity
- 3 September 2026 – 2 September 2029
- Named developmental modules
- AbilityScore mapping, Prognose, Everyday Therapy through TherapeuticAI, tracking and correction through Fusion
What this supports
The supplied BIS licence and schedule cover the specified software design, development, verification, validation, release, deployment, maintenance, support and post-market surveillance. The schedule names developmental mapping, planning, everyday practice, tracking and correction, with school, speech, motor, Study IQ, behaviour, self-sufficiency and mainstream-inclusion readiness modules across the developmental lifecycle.
Scope & limits
The licence applies to its schedule and listed address. It is not a guarantee of clinical outcomes for a child.
This September 2026 licence supersedes the “application pending” status in older company publications.
Source: Original BIS licence, page 1; scope schedule, page 2.
Collection inspected: · Scope rechecked: 19 September 2026 · Current issuer or registry status: not independently confirmed.
The exact source
Section linkassociated digital developmental support modules for the full developmental lifecycle of children.
Open the source-copy page to inspect the quoted wording in context. Existing redactions remain visible.
Source inspection: . Quoted wording compared with the complete public source-copy page. Full developmental lifecycle is wording in the BIS schedule describing the named software/module quality-system scope. Preserve the MD-5 non-diagnostic intended use, ages 0-12 and model/version separately; this phrase does not establish lifelong clinical indication or guaranteed outcomes.
Record revision history
- — Added visually checked source excerpt, exact PDF page link and source-copy preview.
Cite this evidence summary
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This page summarizes the listed evidence; it is not an issuer’s verification service. A source review is separate from checking current issuer status.