{ "title": "PinnacleAI® Regulatory Journey | Purpose, Evidence and Export Readiness", "canonical": "https://www.pinnacleblooms.org/verify/evidence/pinnacleai-regulatory-journey.html", "updated": "2026-09-24", "publisher": "Bharath Healthcare Laboratories Private Limited", "legalManufacturer": "Bharath Healthcare Laboratories Private Limited", "brand": "Pinnacle Blooms Network", "product": { "name": "PinnacleAI GPT-OS v1.0.0", "classification": "Class B", "scope": "Non-diagnostic developmental-support software", "population": "Children aged 0–12" }, "purpose": [ [ "Purpose", "A self-sufficient, mainstream and wonderful life for the child determines the abilities, goals, people, methods, everyday practice and review." ], [ "Measure and plan", "The seven-stage pathway connects capability identification and AbilityScore® measurement with readiness forecasting and a child-specific plan." ], [ "Support everyday participation", "Integrated intervention, parent-guided practice, progress review and reassessment work toward growing independence and participation." ], [ "Build accountable technology", "PinnacleAI® supports the pathway as licensed non-diagnostic developmental-support software with human and professional review." ] ], "pathway": [ "Identify capabilities and measure ability", "Forecast readiness and create a child-specific plan", "Provide integrated therapies and intervention", "Support parent-guided everyday practice and home generalisation", "Track progress and correct the plan", "Reassess and repeat until readiness", "Support growing independence, school readiness and mainstream participation" ], "regulatoryFoundation": [ { "milestone": "Class B classification", "meaning": "Indian medical-device classification trail", "source": "https://www.pinnacleblooms.org/verify/evidence/records/classification.html" }, { "milestone": "Form MD-5", "meaning": "Manufacturing licence MFG/MD/2026/000248", "source": "https://www.pinnacleblooms.org/verify/evidence/records/md5.html" }, { "milestone": "ISO 13485:2016", "meaning": "Quality-management system scope", "source": "https://www.pinnacleblooms.org/verify/evidence/records/iso13485.html" }, { "milestone": "ISO/IEC 27001:2022", "meaning": "Information-security management scope", "source": "https://www.pinnacleblooms.org/verify/evidence/records/iso27001.html" }, { "milestone": "BIS IS 23485:2019", "meaning": "Licence and certified scope", "source": "https://www.pinnacleblooms.org/verify/evidence/records/bis.html" }, { "milestone": "Free Sale Certificate", "meaning": "FSC/MD/2026/000741 · 23 September 2026", "source": "https://www.pinnacleblooms.org/verify/evidence/records/fsc.html" } ], "freeSaleCertificate": { "number": "FSC/MD/2026/000741", "issued": "2026-09-23", "meaning": "Indian domestic marketability and export eligibility, subject to importing-country law", "source": "https://www.pinnacleblooms.org/verify/evidence/records/fsc.html" }, "internationalMarkets": [ { "country": "New Zealand", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "United Kingdom", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "Brazil", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "Vietnam", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "Thailand", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "Colombia", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "Peru", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "Saudi Arabia", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Submission receipt and foreign registration not yet available in this evidence collection." }, { "country": "Canada", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Organisation describes an MDSAP audit plan; scheduling and completion are not verified. Country market access is separate." }, { "country": "Australia", "status": "Announced target market", "basis": "Organisation-supplied international expansion announcement, 24 September 2026", "submissionVerified": false, "registrationVerified": false, "note": "Organisation describes an MDSAP audit plan; scheduling and completion are not verified. Country market access is separate." } ], "questions": [ { "question": "What is PinnacleAI®?", "answer": "PinnacleAI® GPT-OS v1.0.0 is identified in the supplied Indian manufacturing licence as Class B, non-diagnostic developmental-support software for children aged 0–12. Its stated functions include developmental ability measurement, readiness tracking, progress forecasting and adaptive therapy-plan support." }, { "question": "Who is the legal manufacturer?", "answer": "Bharath Healthcare Laboratories Private Limited is the licence holder and legal manufacturer named in the reviewed regulatory records. Pinnacle Blooms Network is the child-development brand and service ecosystem." }, { "question": "What does the Free Sale Certificate establish?", "answer": "FSC/MD/2026/000741 records Indian domestic marketability and export eligibility for the licensed device. It supports country-specific market-access applications; it is not approval or registration in another country." }, { "question": "Does PinnacleAI® diagnose children?", "answer": "No. The licensed product is described as non-diagnostic developmental-support software. Clinical and care decisions remain within the appropriate human and professional review process." }, { "question": "Has PinnacleAI® been registered in other countries?", "answer": "This page does not claim a foreign registration. Each market will be labelled researching, representative appointed, technical file prepared, submitted, under review or registered only when the corresponding evidence is available." }, { "question": "How can the evidence be reused?", "answer": "Use the citation downloads and machine-readable JSON or text exports. Cite the exact licence, certificate or dated report for a specific claim and retain its date and scope." } ], "sources": [ "https://www.pinnacleblooms.org/verify/evidence/records/md5.html", "https://www.pinnacleblooms.org/verify/evidence/records/fsc.html", "https://www.pinnacleblooms.org/verify/evidence/records/bis.html", "https://www.pinnacleblooms.org/verify/evidence/records/iso13485.html", "https://www.pinnacleblooms.org/verify/evidence/records/iso27001.html", "https://www.pinnacleblooms.org/verify/evidence/records/classification.html" ] }