/**
 * FDA 21 CFR Part 820 — Quality System Regulation (QSR) Compliance Pack
 *
 * Quality System Regulation for finished medical device manufacturers
 * selling in the United States. Effective since 1996; superseded the
 * 1978 GMP (Good Manufacturing Practices) requirements.
 *
 * Standards referenced:
 *   - 21 CFR Part 820 (QSR) — subparts B through O
 *   - 21 CFR Part 820 Subpart B: Management Responsibility (§ 820.20–820.25)
 *   - 21 CFR Part 820 Subpart C: Design Controls (§ 820.30)
 *   - 21 CFR Part 820 Subpart D: Document Controls (§ 820.40)
 *   - 21 CFR Part 820 Subpart E: Purchasing Controls (§ 820.50)
 *   - 21 CFR Part 820 Subpart F: Identification & Traceability (§ 820.60–820.65)
 *   - 21 CFR Part 820 Subpart G: Production & Process Controls (§ 820.70–820.75)
 *   - 21 CFR Part 820 Subpart J: Corrective & Preventive Action (CAPA) (§ 820.100)
 *   - 21 CFR Part 820 Subpart L: Handling/Storage/Distribution/Installation (§ 820.140–820.170)
 *   - 21 CFR Part 820 Subpart M: Records (§ 820.180–820.198)
 *   - 21 CFR Part 820 Subpart N: Servicing (§ 820.200)
 *   - 21 CFR Part 820 Subpart O: Statistical Techniques (§ 820.250)
 *   - 21 CFR Part 803 (Medical Device Reporting — MDR): 30-day / 5-day clocks
 *   - QMSR (FDA Quality Management System Regulation, Feb 2024): harmonises
 *     21 CFR Part 820 with ISO 13485:2016. Compliance deadline: 6 Feb 2026.
 *     Legacy QSR systems still valid under transition; this pack supports BOTH.
 *
 * Key data records:
 *   DHF  — Design History File (§ 820.30(j))
 *   DMR  — Device Master Record (§ 820.181)
 *   DHR  — Device History Record (§ 820.184)
 *   CAPA — Corrective and Preventive Action record (§ 820.100)
 *
 * Retention: device lifetime + 2 years per § 820.180(b). This pack uses
 * 10,950 days (≈ 30 years) as a conservative representative lifetime + buffer,
 * consistent with FDA industry practice for long-lifetime implantable devices.
 * Implementers MUST configure actual device lifetime for their product class.
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * FDA 21 CFR Part 820 / QSR category classifiers.
 *
 * Records are classified by their regulatory role under the QSR.
 * Unauthorised modification of controlled records is BLOCKED.
 * Regulated quality records carry mandatory audit trails.
 */
export declare const FDA_21_CFR_820_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const FDA_21_CFR_820_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
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