Compliance & Quality
NABL and ISO 15189:2022 documentation, built into every slide
PathStandard provides manufacturer-issued Certificates of Analysis with lot number, quality specifications, and pass/fail determination for every slide — directly supporting ISO 15189:2022 Clause 6.6 consumable traceability, NABL 112A criteria, ISO 13485 QMS alignment, and CDSCO Class A IVD classification under MDR 2017.
Trust Framework
Built for modern pathology workflows
Every slide gets a permanent ID, batch-level records, and quality documents that are easy to show during audits.
Serialized
Unique Slide Identity
A permanent laser-etched barcode on every slide.
Traceable
Full Tracking History
Digital records from factory to archive.
CoA Verified
Certificate of Analysis
Download a PDF quality certificate in under 10 seconds with a phone scan.
NABL Ready
Supports Accreditation
Documentation aligned with ISO 15189:2022 audit needs.
Aligned with / Compliant with
Standards & Clauses
Built for NABL audits. Designed around ISO 15189:2022.
Each PathStandard capability maps directly to a specific standard or clause your assessors check — so compliance documentation is satisfied by design, not by manual preparation.
Clause 6.6 — Reagents & Consumables
PathStandard provides a manufacturer-issued Certificate of Analysis with lot number, quality specifications, and pass/fail determination for every slide lot — downloadable as a PDF in under 10 seconds, directly satisfying consumable traceability requirements.
Specific Criteria for Medical Laboratories
NABL requires documented traceability for all reagents and consumables under ISO 15189:2022. PathStandard's cloud quality database provides this lot-level documentation for every slide, with a tamper-evident access log for assessors.
Medical Device Quality Management
PathStandard manufacturing is aligned with ISO 13485 QMS requirements, ensuring systematic quality control and documented production records at the point of manufacture.
Class A IVD Classification
Microscope slides are classified as Class A In Vitro Diagnostic devices under India's Medical Device Rules 2017. PathStandard products are manufactured and documented accordingly.
QR Code Symbology (ISO/IEC 18004)
Each slide carries a QR code with error correction, ensuring reliable scan readability by any phone camera or 2D barcode reader — even with partial label wear after staining and clearing.
2D Barcode Print Quality
QR codes are produced to Grade A print-quality specifications, ensuring consistent readability across phone cameras, lab scanners, and whole-slide imaging systems.
Important Product Information
PathStandard serialized slides are Class A In Vitro Diagnostic (IVD) medical devices under India's Medical Devices Rules (MDR) 2017 and the CDSCO classification framework.
Slides are intended for use in clinical and research pathology laboratories. Quality certificates (CoA) provide manufacturer lot data and should be reviewed alongside your lab's standard quality procedures.
Scan results and CoA downloads are provided for documentation and audit support. They do not replace your lab's internal quality management system or assessor judgment.
Quality & Regulatory Information
PathStandard manufacturing is aligned with ISO 13485 Quality Management System requirements. Documentation supports ISO 15189:2022 Clause 6.6 consumable traceability needs for NABL-accredited laboratories.
Slide QR codes comply with ISO/IEC 18004 2D barcode standards. Quality records are stored with encryption and maintained as immutable entries from the point of manufacture.
For regulatory inquiries, contact hello@pathstandard.in. Product specifications are subject to change. Intended for laboratory and healthcare professional use in India and APAC markets.
Get Started
See your first serialized slide.
Request an evaluation kit and experience permanent slide identity, cloud traceability, and digital provenance first-hand.
+1 (224) 804-4106 · contact@pathstandard.in
Made in India · ISO 13485 aligned · Singapore HQ · CDSCO Class A IVD — registration in progress