Medical Device Manufacturing
Manufacturing Execution for FDA QMSR and ISO 13485
Qontiv is designed to slot into a Class II or Class III medical device manufacturer's quality system without rebuilding it. Native DHR generation, CAPA, MSA, and 21 CFR Part 11 e-signatures — all in one MES.
QMSR is in effect. Your transition window closes February 2, 2028.
FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820 revised) went into effect on February 2, 2026. Manufacturers have until February 2, 2028 to align. We're inside the 2-year window — FDA inspectors are already referencing the new rule. Buyers who start their MES evaluation now have time to pilot, validate, and go live before the window closes.
If you're rebuilding your QMS for QMSR, Qontiv's MES+QMS-in-one approach is structurally different from a standalone QMS bolted to your shop floor. CAPA records reference the work order. DHRs auto-generate from production transactions. Genealogy is captured at the point of work, not reconstructed from spreadsheets. Migration from Greenlight Guru, MasterControl, or a paper QMS includes a structured data-export playbook and a 4-week pilot.
Quality modules designed for ISO 13485 and 21 CFR Part 820
Device History Records (DHR)
Auto-generated PDF per serial or lot. Ten section composers cover DMR conformance, production operations, in-process inspections, acceptance activities, genealogy, NC/CAPA references, label reconciliation, and a signatures index. Immutable archive with SHA-256 hash and retention policy (ClassIII: 10 yr, ClassII: 7 yr). Re-generated automatically when linked quality events occur.
- • 21 CFR 820.184 — Device History Record per production unit or lot
- • 21 CFR Part 11 §11.50 — e-signature index with printed name + datetime + meaning
CAPA & Nonconformance
State-machine governed CAPA: Initiated → RootCauseAnalysis → ActionPlan → Implementation → EffectivenessVerification → Closed. Root-cause method tracking (5-Why, Fishbone, Fault Tree). NC trend thresholds with auto-CAPA creation — configurable rolling window and count trigger. E-signatures at gated transitions.
- • ISO 13485 §8.5.2 / §8.5.3 — corrective and preventive action
- • 21 CFR 820.100 — CAPA procedures
- • IATF 16949 §10.2 / AS9100 Rev D §10.2
Risk Management (ISO 14971)
Risk file per part revision with severity × probability matrix. Risk re-assessment triggered on Engineering Change Order (ECO). Full traceability from hazard to control measure.
- • ISO 14971 — medical device risk management
- • ISO 13485 §7.1 — risk-based approach
Measurement Systems Analysis (MSA)
Gauge R&R per AIAG MSA 4th edition acceptance criteria (%GRR <10% Accepted, 10–30% Conditional, >30% Rejected). Gauge master records, calibration interval tracking, and status states (Active / Quarantined / AwaitingCalibration / Retired).
- • IATF 16949 §7.1.5.1.1 — MSA requirement for gauges in control plan
- • ISO 13485 §7.6 — monitoring and measuring equipment
Lot Genealogy & Traceability
Full forward and backward lot genealogy. Recall scope determination query returns every affected serial or lot in seconds, not hours. Genealogy is captured at the point of work — not reconstructed after the fact.
- • 21 CFR 820.65 — traceability for implant and life-supporting devices
- • ISO 13485 §8.3 — identification and traceability
Electronic Signatures
21 CFR Part 11 §11.50 signing ceremony on every gated operation — printed name, datetime, and signing meaning are captured and stored. Immutable once signed. Surfaced in DHR signatures index.
- • 21 CFR Part 11 §11.50 — signature manifestations
- • 21 CFR Part 11 §11.10(e) — audit trail for operator actions
Validation Package (GAMP 5)
GAMP 5 categorization (Cat 4 — configurable software). Includes IQ/OQ/PQ templates, 21 CFR Part 11 §11.10 mapping, CSA customer playbook, UAT scripts per module, and auto-generated traceability matrix. The IT/QA acceptance gate — reduces validation effort to a review exercise.
- • GAMP 5 — computerized system validation
- • 21 CFR Part 11 §11.10 — controls for closed systems
What this is — and what it isn't
Qontiv is not certified to ISO 13485 — the certification belongs to the manufacturer. Qontiv is designed to be compatible with a medical device manufacturer's certified quality management system, providing the records, controls, and traceability that auditors and inspectors look for. Your MDSAP or ISO 13485 certification body audits you; Qontiv supplies the evidence.
FDA QMSR is in effect. Are you ready?
Auto-generated DHRs, native CAPA, and MSA — designed for ISO 13485 and 21 CFR Part 820.