FDA Regulatory Compliance Program

1.0 — Quality System Regulation (21 CFR Part 820)

Veridian Corp maintains a quality management system aligned with 21 CFR Part 820 and ISO 13485:2016. All manufacturing, design, and distribution activities for medical devices are governed by documented procedures subject to internal audit and FDA inspection readiness.

All medical device design and manufacturing activities must comply with 21 CFR Part 820 Quality System Regulation requirements at all times.

Management reviews of the quality system must be conducted at least annually, with documented action items tracked to closure within 90 days.

Internal quality audits must be performed at minimum every 12 months covering all QSR subparts applicable to Veridian device classes.

Corrective and Preventive Action (CAPA) records must be initiated within 5 business days of identification of a quality system nonconformance.

Device History Records (DHR) must be maintained for every manufactured unit and retained for the lifetime of the device plus 2 years after discontinuation.

Supplier controls per 21 CFR 820.50 require approved vendor qualification before any component affecting device safety is procured.

QSR Subpart Compliance Matrix

Download: FDA QSR Audit Checklist 2026 (PDF) · ISO 13485 Certificate (PDF)

2.0 — Premarket Notification (510(k)) Requirements

All Class II devices require FDA 510(k) clearance before commercial distribution. Veridian maintains a Design History File (DHF) for each cleared device and tracks predicate device relationships per FDA guidance.

No Class II medical device may be marketed until FDA 510(k) clearance is received and documented in the Regulatory Affairs database.

Substantial equivalence determinations must be documented with predicate device 510(k) numbers, product codes, and intended use comparisons before submission.

All labeling, promotional materials, and IFU documents for 510(k)-cleared devices must match the cleared indications for use statement exactly.

Device modifications that could affect safety or effectiveness require a regulatory assessment and may necessitate a new 510(k) submission per FDA guidance.

510(k) summary documents must be published on the Veridian regulatory website within 30 days of FDA clearance.

Active 510(k) Clearances

3.0 — Medical Device Reporting (21 CFR Part 803)

Veridian Corp is required to report deaths, serious injuries, and device malfunctions to FDA when the device may have caused or contributed to the event.

All reportable adverse events must be evaluated by the Regulatory Affairs team within 5 business days of becoming aware of the event.

FDA Form 3500A (MDR) must be submitted within 30 calendar days for all reportable events under 21 CFR 803.50.

Events requiring remedial action to prevent unreasonable risk must be reported to FDA within 5 working days per 21 CFR 803.53.

Complaint records must be maintained per 21 CFR 820.198 and cross-referenced with MDR submissions in the complaint management system.

Trend analysis of complaint and MDR data must be performed quarterly and presented to the Quality Review Board.

See full procedures: MDR Reporting Procedures SOP-MDR-001 (PDF) · 21 CFR Part 803 Reference Page

4.0 — FDA Device Classification

5.0 — Design Controls (21 CFR 820.30)

Design and development planning must produce a documented Design Plan before any design activity begins on a new or modified device.

Design inputs must be documented, reviewed, and approved before design outputs are finalized; traceability matrices must link inputs to outputs and verification activities.

Design verification must demonstrate that design outputs meet design inputs through objective evidence including test protocols and acceptance criteria.

Design validation must be performed on initial production units, lots, or equivalents under actual or simulated use conditions.

Design changes must be identified, documented, verified or validated as appropriate, and approved before implementation per the change control procedure.

Design History Files must be maintained for the life of the device and include or reference all design control records.

6.0 — Labeling & UDI Requirements

All device labels must include the device name, model number, manufacturer name and address, and UDI per 21 CFR 801.20 where applicable.

Instructions for Use (IFU) must be provided with every device and must match the cleared 510(k) labeling exactly.

Unique Device Identification (UDI) data must be submitted to the GUDID database before commercial distribution of Class II devices.

Promotional materials must be reviewed by Regulatory Affairs before external distribution to ensure consistency with cleared indications for use.

7.0 — Electronic Records (21 CFR Part 11)

Systems used to create, modify, maintain, or transmit electronic records subject to FDA regulations must comply with 21 CFR Part 11.

Electronic records used for FDA-regulated activities must be attributable, legible, contemporaneous, original, and accurate (ALCOA+ principles).

Electronic signatures must be unique to each individual, verified before use, and linked permanently to their respective electronic records.

Audit trails for Part 11 systems must capture who, what, when, and why for all create, modify, and delete operations on GxP records.

Computer system validation (CSV) documentation must be maintained for all systems storing or processing FDA-regulated electronic records.

8.0 — Post-Market Surveillance

Post-market surveillance plans must be maintained for all Class II devices and reviewed annually by Regulatory Affairs.

Field correction and removal actions (recalls) must follow 21 CFR Part 806 procedures with FDA notification within required timeframes.

Periodic safety update reports must be prepared for devices with active post-market study commitments.

Customer complaint trending must trigger CAPA investigation when complaint rates exceed established control limits.