Medical Device Audit Services: Be Audit-Ready, Every Time

Structured audit preparation prevents shipment holds, FDA Form 483 citations, and EU-MDR major non-conformities, thus protecting product quality, supply chains, and patients

01

FDA warning-letter remediation can cost $600 k–$1 million and delay revenue six months or more

02

Design-control deficiencies remain the most common quality-system finding in FDA inspections, highlighting chronic preparation gaps

03

Supplier issues drive a large share of non-conformities, yet systematic vendor audits can cut findings by ~40%

Comprehensive Audit & Inspection Services for Medical Devices

Every audit probes your entire quality ecosystem—from design files to supplier records—so genuine medical device inspection readiness demands more than a checklist.

Veranex fuses strategic compliance planning—roadmaps that guide your smooth transition to the upcoming FDA QMSR and sustain ISO 13485 alignment—with FDA mock inspections, Notified-Body prep, and MDSAP audit support in one streamlined program that uncovers gaps months early and reduces potential for non-conformities.

Internal QMS Inspections

Detect gaps early and train teams for regulatory success

Detect gaps early and train teams for FDA success
Gap assessments + readiness reviews mapping ISO 13485 clauses to the new FDA Quality Management System Regulation (QMSR).
Timeline alignment: roadmap for the QMSR transition deadline February 2026.
Navigate the phase-out of QSIT: understand changes and stay inspection-ready as FDA retires QSIT in 2026.
MDSAP internal-audit prep: verify your QMS meets all five partner-regulator requirements before the official MDSAP audit.
Mock FDA inspections simulating the updated inspection model to reduce risk and boost confidence.
Corrective-and-Preventive-Action planning with effectiveness checks.
Front-room / back-room team coaching for zero-surprise inspection performance.

Supplier & Contract Manufacturer Audits

Qualify vendors, cut non-conformities, safeguard supply chain

On-site or virtual ISO 13485 supplier audits
Vendor qualification, risk ranking, and outsourced-process verification.
Compliance checking of client-specific requirements and outsourced processes
Tracking and closure of supplier non-conformities

Regulatory-Prep Mock Inspections

Rehearse FDA, Notified Body, and MDSAP audits to avoid costly holds

Full FDA mock audit, including design-control focus areas
Notified-Body inspection preparation under the EU MDR and IVDR.
Medical Device Single Audit Program (MDSAP) simulations with consolidated global checklists.
Issue remediation roadmap plus management-review briefing to secure green-light for the real inspection.

90-Day Audit-Readiness Roadmap

Proactive medical device audit services convert last-minute scrambling into disciplined inspection readiness. The phased plan aligns with FDA QMSR, ISO 13485, EU MDR, and MDSAP criteria, surfacing gaps months before regulators arrive.

Week 0 – 2 Scope & Gap Scan

Launch with a QMSR-aligned gap assessment that benchmarks design controls, production, CAPA, and supplier files against ISO 13485, EU MDR, and MDSAP clauses. Early scoping sets the risk profile and prioritized action list.

Week 3 – 6 Mock Audit & CAPA Close-out

Run a live FDA mock inspection—or Notified-Body or MDSAP simulation—that mirrors the updated inspection flow. Capture objective evidence, then draft and close corrective-and-preventive actions before regulators arrive.

Week 7 – 10 Evidence Roll-up & Staff Rehearsal

Compile traceable document packets, update quality manual, and rehearse front-/back-room scripts—critical for ISO 13485, EU MDR, and MDSAP audit support. Table-top drills ensure every SME can navigate design-file and supplier-quality questions on demand.

Week 11 – 12 Executive Go / No-Go Gate

Leadership reviews CAPA evidence, updated SOPs and documentation, training records, and risk assessments against acceptance criteria set on Day 1. Any final quality-system updates or team retraining needed for QMSR, ISO 13485, EU MDR, or MDSAP benchmarks is completed here. Passing the gate green-lights formal submission to FDA, the Notified Body, or the MDSAP auditor—closing the loop on comprehensive medical-device audit readiness.

Cédric Razaname

Director, Quality and Regulatory Affairs

Jinna Buhagiar

Sr Quality Systems Manager

Paige Sutton-Smith

Quality and Regulatory Affairs Manager

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Notified Body Audit Support

Situation

A mid-sized medical device manufacturer faced mounting pressure as their critical Notified Body audit approached. The CEO expressed concerns following their previous audit experience, marked by documentation gaps, team confusion during auditor interviews, and difficulty interpreting regulatory requirements.

With limited internal quality resources and a complex regulatory landscape, leadership recognized they needed expert guidance to avoid repeating past mistakes.

Successes

Through systematic gap analysis and mock audit simulations, Veranex identified critical documentation deficiencies and trained key personnel on effective auditor interaction techniques. Our team guided the remediation of all identified gaps, established robust document control processes, and conducted intensive coaching sessions. The result: the company achieved a successful NB audit with zero major non-conformities and ensured they are well-prepared for other future audits.

Services by Veranex

Comprehensive Gap Assessment
Documentation Remediation
Mock Notified Body Audit
Team Training & Coaching

Quality Management Systems

ISO 13485 QMS locks quality early—pre-empting audit findings

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Process Validation Services

First-pass process validation success for any manufacturing, sterilization, or packaging process.

Quality Validation Consulting

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Scalable Manufacturing Solutions

Our manufacturing team can support supply chain logistics as well as prototype builds through controlled builds for product launch.

Manufacturing Solutions

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Regulatory Consulting Services

Ensure your plan from concept-to-commercialization is defined for regulatory success.

Regulatory Services

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Request Your Audit Readiness Map

We’ll scope your gaps, timeline, and resource needs so you succeed the first time.

Contact us