Feature

Verified Knowledge
Management

Every piece of content has a named owner, an approval record, a version history, and a next-review date. Users always see the current approved version.

SPEC-MED-8492 //
Cardiac_Ablation_Catheter_v4.2.pdf
ISO 13485:2016 Compliant

Engineering Release Spec

High-Frequency Ablation Generator Array

Approved

Version

v4.2 (Active)

Approved Date

14 Jan 2026

Next Review

Oct 2026

Review Cadence

Annual (Q4)

MW

Named Authority

Dr. M. Weber

VP Product Engineering

Cryptographic Checksum

SHA-256: 7f89d3a0...c14e82

Verified Ledger Entry #8942

Lifecycle Status: Live in 18 Enterprise Portals

Auto-Synced

Audit ready foundation

Total accountability by architectural design

A named owner.

Every document has a named owner and an approval record.

MWOwner: Dr. M. Weber · Signed off: 14 Jan 2026

The current approved version.

Users always see the current approved version. Previous versions are retained for audit purposes.

v4.2 Active (Live) · v4.1 Archived for Regulatory Review

A review date.

Each record has a next-review date, with an audit trail to support your internal quality processes.

Next Review: Oct 2026 · Cadence: 12 months

Structured workflow

Content is organised, not just stored

  1. 1

    Structured Intake

    Add a document to a structured product record and name its owner.

  2. 2

    Cross-Functional Governance

    Route it through internal approvals.

  3. 3

    Targeted Distribution

    Publish the approved version with a review date.

Document taxonomy & record target

Cardiology / Ablation Systems / Generator_IFU_EU_2026.pdfClass III MedDevice

Required approval gateways

VP Product Engineering

Dr. M. Weber · Signed 14 Jan 2026 09:14 CET

Executed

Director Regulatory Compliance

E. Vance, RAC · Signed 14 Jan 2026 11:22 CET

Executed

Automated cadence trigger

Automated ISO 9001 Cycle

Published with scheduled mandatory re-evaluation set for October 14, 2026. Automated alerts will broadcast to owners 45 days prior.

Cross-functional precision

One source of product truth for every team that depends on it

SalesServiceTroubleshootingTraining

Regulatory Traceability

Export unalterable audit trails proving that global service technicians and field clinicians referenced only FDA/CE-cleared procedures.

Clinical Affairs Sign-Off

Establish immutable review sign-offs before clinical claims or contraindication revisions become visible to commercial teams.

Distributor Catalog Integrity

Prevent outdated specifications and decommissioned part numbers from circulating across 3rd-party dealer networks.

Explore the platform

Related features

Built as an integrated continuum of verified knowledge, governance, and learning.

Feature

AI Product Search

Your teams and channel partners ask questions in plain language. Kiavi IQ searches only approved content they can access.

/features/ai-search

Feature

Permission-Controlled Access

One platform, multiple audiences. Internal staff, distributors, dealers, and B2B customers each access only what is approved for their role.

/features/permissions

Feature · Continuous Competency

Courses and Assessments

Build product training courses from your approved product knowledge. Assign learning by role.

/features/learning

Frequently asked questions

No. Kiavi AI stores product documents, but it also turns them into structured product records, AI answers with sources, and training.

Ready to give your teams verified product knowledge?

Empower engineering, commercial, and technical service teams with a single, audit-certified source of truth.