Sold by: Kriv AI
Kriv AI authors a Predetermined Change Control Plan (PCCP) for AI/ML-enabled medical devices seeking FDA clearance via 510(k) or De Novo. Aligned with FDA Dec 2024 final guidance "Marketing Submission Recommendations for a PCCP for AI-Enabled Device Software Functions." Scope: Device Description + Modification Description + Modification Protocol (data management, re-training, V&V, labeling) + Impact Assessment + Algorithm Change Protocol + ISO 14971 clinical risk + cybersecurity premarket (Sep 2023 + Section 524B PATCH Act + SBOM) + RWPM plan + GMLP 10-principle gap analysis + Q-Sub briefing (Enterprise). Three tiers: $65K Foundation (6 wks, 1 device) / $125K Standard (8 wks, +GMLP +cybersecurity +RWPM) / $225K Enterprise (12 wks, +multi-device +Q-Sub +DHCoE +post-market +TAP). +$25K per additional pre-specified modification.
Overview
FDA finalized the PCCP guidance December 4, 2024. Without a PCCP, every substantive algorithm modification requires a new 510(k) ($100K–$500K per submission + 3–9 months FDA review). With a cleared PCCP, pre-specified modifications deploy without new submission. QMSR 21 CFR Part 820 effective February 2, 2026 harmonizes with ISO 13485. Zero FDA PCCP authoring SKUs exist on AWS Marketplace today. Kriv AI is first.
VP Regulatory Affairs, CROs, Heads of QA, Heads of AI/ML Product, CSOs, CMOs, and startup CEOs / CTOs at AI/ML SaMD + SiMD manufacturers, non-exempt CDS vendors, radiology AI (Aidoc, Viz.ai, RapidAI, HeartFlow), pathology AI (Paige, PathAI), cardiology AI (Eko, AliveCor, iRhythm), ophthalmology AI (Digital Diagnostics, Eyenuk), oncology AI (Tempus, Caris), surgical AI (Proprio, Theator), clinical documentation AI (Abridge, Suki, DeepScribe, Nuance DAX), and established medtech AI pipelines (GE HealthCare, Philips, Siemens Healthineers, Medtronic, J&J MedTech) face the same binding obligation: FDA December 2024 final guidance sets the PCCP as the productized mechanism for AI/ML device lifecycle management, and competitive AI/ML vendors who achieve PCCP-cleared posture gain material feature-velocity advantage. FDA has cleared 1,000+ AI/ML-enabled devices since 2017. GMLP 10 principles (FDA + Health Canada + UK MHRA, 2021/2024) are now table-stakes PCCP framing.
Kriv is first with a dedicated fixed-fee FDA PCCP authoring SKU on AWS Marketplace — regulated-healthcare-anchored, GMLP-integrated, QMSR-harmonized, AWS HealthLake / HealthOmics / SageMaker linked, Anthropic CPN-certified. Off-Marketplace alternatives include RQM+ ($150K–$500K full 510(k)), NAMSA, Emergo, Greenleaf Health ($600–$900/hr), boutique SaMD specialists ($50K–$300K), ex-FDA CDRH consultants ($400–$600/hr), and law firms (Hogan Lovells / Hyman Phelps / Arnold & Porter — $800–$1,400/hr partner rates).
Engagement methodology (6–12 weeks). Weeks 1–2 device scoping + regulatory posture (SaMD classification per IMDRF; indications for use; prior 510(k) / De Novo / PMA / 513(g) history; FDA correspondence review). Weeks 3–6 (Foundation closes) core PCCP authoring per FDA Dec 2024 final guidance — 4 required sections (Device Description; Modification Description; Modification Protocol covering data management, re-training SOPs, performance evaluation, V&V, labeling; Impact Assessment with cumulative + residual risk) plus ISO 14971 AI-specific risk assessment (data drift, population drift, automation bias, adversarial inputs) and labeling changes inventory. Weeks 7–8 (Standard) GMLP 10-principle gap analysis matrix + cybersecurity premarket linkage per FDA Sep 2023 guidance + Section 524B PATCH Act + SBOM per NTIA / CISA + real-world performance monitoring plan. Weeks 9–12 (Enterprise) multi-device portfolio PCCP + Q-Sub briefing + FDA DHCoE engagement strategy + TAP eligibility evaluation + post-market surveillance protocol (21 CFR Part 822 / Section 522).
Three tiers. Foundation $65K (6 wks; single-device single-indication PCCP with up to 3 pre-specified modifications; 4-section PCCP + ACP + ISO 14971 + labeling). Standard $125K (8 wks; Foundation + GMLP + cybersecurity + RWPM + up to 6 modifications). Enterprise $225K (12 wks; Standard + multi-device portfolio + Q-Sub + DHCoE + TAP + post-market surveillance + up to 10 modifications). Additional modification +$25K each.
Important disclosures. Kriv does NOT provide legal advice. Customer regulatory counsel retains all FDA-submission legal-strategy decisions. No FDA clearance / 510(k) / De Novo / Q-Sub / DHCoE / TAP / Breakthrough Device outcome guarantee. Customer RA retains all FDA submission signatures + correspondence authority; Kriv does NOT sign FDA filings. Does NOT replace QSR / QMSR / ISO 13485 audit, FDA inspection defense, recall / CAPA, MDR / MedWatch filings, full ISO 14971 build, full IEC 62304 build, IEC 62366 build, or 21 CFR Part 11 validation. Customer clinical validation + dataset preparation remain Customer's scope. Kriv is NOT a US Agent for FDA purposes. QMSR transition Feb 2, 2026 monitored. One-time PCCP authoring; ongoing post-market lifecycle → N2 follow-on. Anthropic CPN-certified partner, not Anthropic-authorized reseller.
Highlights
- First FDA PCCP authoring SKU on AWS Marketplace Professional Services. FDA finalized PCCP guidance December 4, 2024. Without PCCP, every algorithm modification = new 510(k) ($100K–$500K + 3–9 months FDA review). With cleared PCCP, pre-specified modifications deploy without new submission. QMSR 21 CFR Part 820 effective February 2, 2026 harmonizes with ISO 13485. Zero direct Marketplace competitors today; 12–24 month first-mover window before RQM+ / NAMSA / Greenleaf list Marketplace SKUs.
- FDA Dec 2024 final guidance four-section PCCP authoring (Device Description + Modification Description + Modification Protocol + Impact Assessment) + Algorithm Change Protocol + ISO 14971 AI-hazard risk assessment + GMLP 10-principle gap matrix + cybersecurity premarket (Sep 2023 + Section 524B PATCH Act + SBOM per NTIA/CISA) + RWPM plan + Q-Sub briefing + DHCoE engagement + TAP eligibility.
- $65K Foundation (6 wks, single-device + 3 modifications) / $125K Standard (8 wks, + GMLP + cybersecurity + RWPM + 6 modifications) / $225K Enterprise (12 wks, + multi-device portfolio + Q-Sub + DHCoE + TAP + post-market surveillance + 10 modifications). +$25K per additional pre-specified modification. AWS HealthLake + HealthOmics + SageMaker + Bedrock linked. Anthropic CPN-certified. Customer RA retains FDA submission signatures; Kriv does not file. Not a US Agent.
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Primary support contact. info@kriv.ai · +1-732-433-5564 · https://kriv.ai/support
Response SLA. 2 US business days (Mon–Fri 9 am – 6 pm ET, US federal holidays excluded). Standard tier 1 business day. Enterprise tier 4-hour response for pre-Sub / Q-Sub / FDA correspondence escalation.
Engagement onboarding. First contact within 2 US business days of marketplace inquiry / private-offer acceptance. Kickoff within 3–5 weeks of countersigned SOW (QMS prerequisite alignment).
Escalation path. Engagement Lead (named in SOW) → Practice Director (info@kriv.ai ) → CEO Abhinav Dangri (info@kriv.ai ).
Communication. Dedicated Teams channel, weekly 60-min checkpoint, Friday status note. Customer SMEs 4–8 hrs/week (VP RA, Head of QA, CSO, Head of AI/ML Product, Head of Data Science, Head of Engineering, Head of Clinical Affairs, Head of Post-Market Surveillance). External regulatory counsel welcome.
Documentation handoff. Device + Modification Description + Modification Protocol + Algorithm Change Protocol as Word; Impact Assessment + ISO 14971 AI-hazards + labeling + GMLP gap matrix as Excel; cybersecurity premarket + SBOM as Word + SPDX; RWPM plan + Q-Sub briefing + post-market surveillance (Enterprise) as Word.
Boundaries. NOT legal advice. Customer RA retains all FDA submission signatures. Does NOT replace QSR / QMSR / ISO 13485 audit, FDA inspection defense, recall / CAPA, MDR / MedWatch filings, ISO 14971 / IEC 62304 / IEC 62366 / Part 11 validation. Customer clinical validation + dataset curation = Customer scope. No FDA clearance guarantee. Kriv NOT a US Agent. AWS infrastructure billed by AWS.
Hours / holiday coverage. Mon–Fri 9 am – 6 pm ET. Closed on US federal holidays except Enterprise 4-hour SLA for active pre-Sub / Q-Sub / FDA correspondence.