Deploy a Robust Medical Device QMS

Structured medical-device QMS consulting shields you from FDA Form 483 and EU-MDR major non-conformities—Veranex synchronizes evidence with Regulatory Affairs..

Building a Quality Medical Device QMS Foundation

A right-sized medical-device QMS locks design risks and user needs into traceable procedures before verification starts—yet it stays lean enough to fuel rapid iteration. By the time you hit clinical trials or design transfer, FDA, EU-MDR, and MDSAP auditors expect documented design controls, CAPA flow, and supplier oversight already running.

Veranex meets innovators wherever they are: seed-stage startups building from scratch, growth firms remediating gaps, or strategics harmonising global files. Early engagement avoids costly re-work and accelerates ISO 13485 certification, FDA compliance, and EU-MDR submissions—delivering safer devices to patients sooner.

Comprehensive QMS Support:

Tailored to 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, and MDSAP
End-to-end procedure development—from seed-stage SOPs to enterprise harmonization
Gap assessments mapped to current standards and regulator expectations
Internal audits & inspection readiness for FDA, NB, and MDSAP visits

Training and mentoring that embeds a sustainable quality culture

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Complete QMS builds delivered—from seed-stage startups to Fortune 500 med-tech leaders.

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FDA, ISO 13485, and MDSAP gap assessments that fast-track inspections, certifications, and global launches.

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Centuries of combined quality expertise driving QMS development, implementation, and continuous improvement.

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A well-designed medical-device QMS is more than a compliance box—it captures design risks, software controls (IEC 62304), and supplier obligations from the start.

Aligning early with ISO 13485, FDA QMSR, EU MDR, and MDSAP standards turns quality into a strategic asset that reassures regulators, investors, and future acquirers.

Veranex applies a phased, right-sized approach: we map every clause against your product roadmap, highlight high-risk gaps, and stage remediation so innovation never stalls. No generic 90-day promises—just a timeline that fits your milestones and budget.

Deliverables

Multi-standard gap matrix with risk scores (ISO 13485, QMSR, EU MDR, IEC 62304, ISO 14971)
Phased implementation timeline tied to design, V&V, and submission gates
Executive slide deck with cost envelope for board/investor alignment
Transition plan from FDA QSR ➜ QMSR, including supplier-quality impacts
Governance playbook: roles, tollgates, management-review cadence

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A robust QMS must live in both people and tools.

Veranex drafts the Quality Manual and procedures, then configures paper-based or eQMS workflows so design, regulatory, and supplier teams share one controlled source of truth—no duplicate records, no chaos.

Deliverables

Quality Manual + right-sized SOP set (typically 20-30, tailored by region & class)
Paper forms or eQMS configuration (Greenlight Guru, MasterControl, etc.)
Legacy-document migration with audit trail
Role-based training & competency sign-offs
Design-phase, pilot/transfer, and software-development SOP tie-ins

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Why it Matters

Regulators judge effectiveness, not paper volume. Audit readiness—whether FDA, Notified-Body, or MDSAP—depends on clean documentation, vigilant post-market surveillance, and a culture of continuous improvement. Gaps delay approvals, trigger findings, and spur costly rework.

Deliverables

QMS documentation audit & gap report (ISO 13485, QMSR, EU MDR)
Audit-readiness plan prioritizing high-risk areas and corrective actions
SOP development / remediation, including vigilance & post-market-surveillance processes
Living QMS-maintenance program: change control, internal audits, management reviews, annual training
Mock inspection simulation to train teams and stress-test controls

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Airborne particulates and bioburden are leading contributors to product recalls and patient risk.

Veranex’s contamination-control programs proactively reduce cleanroom-related CAPA events, strengthening product integrity from development through commercialization. Our experts guide medical-device companies through every stage of cleanroom control, aligning with ISO 14644 for classification and environmental monitoring and ISO 14698 for biocontamination control. Need cleanroom capacity?

Services provided:

ISO 14644 cleanroom classification and environmental-monitoring plans
ISO 14698 bioburden strategy and operator training
Contamination-control risk assessments integrated with design & process validation
Ongoing metrics review and trend analysis to maintain audit-ready conditions

Naghmeh Nouri

Executive Director, Quality Engineering

Sara Wulff

Director, Quality and Regulatory Affairs

Elena Lucano, Ph.D.

Sr Manager, Quality and Regulatory Affairs

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Rapid QMS Overhaul Positions Mid-Sized Firm for Compliance

Situation

A mid-sized medical device firm faced significant QMS issues threatening regulatory compliance: inadequate version control, inconsistent and incomplete records, and accumulating non-conformities lacking proper investigation and closure.

Successes

Veranex implemented a comprehensive QMS transformation and training, culminating in a successful internal audit that verified full QMS implementation, positioning the company for confident ISO 13485 certification and regulatory submissions.

Services by Veranex

QMS Gap Assessment: ISO 13485 compliance evaluation and risk-prioritized roadmap
Custom QMS Design: Tailored procedures balancing compliance and operational efficiency
Process Optimization: Procedures refined to reflect real-world operations
Staff Training: Role-based workshops and competency development
Internal Audit: Comprehensive verification of QMS implementation

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Swiss SaMD Developer Achieves CE Mark via Robust QMS

Situation

A Swiss medical device firm needed comprehensive technical documentation and a Quality Management System (QMS) to achieve CE marking for their Software as a Medical Device (SaMD). Recognizing complex regulatory requirements, they partnered with Veranex for combined regulatory and quality expertise.

Successes

Leveraging a trusted seven-year regulatory partnership, Veranex developed a robust QMS and comprehensive technical documentation, guiding the client seamlessly through the complex CE marking and conformity assessment process under MDD. Our deep regulatory support continues today, facilitating their successful ongoing transition to EU MDR compliance.

Services by Veranex

Comprehensive QMS implementation (ISO 13485, IEC 62304, IEC 82304)
Software development, maintenance, and risk management process guidance provided per IEC 62304 requirements
Tailored, ongoing team training programs
Technical File compliance support for both MDD and MDR requirements
Annual internal auditing services to sustain compliance

Design & Manufacturing Quality

V&V-ready designs feed evidence into QMS records.

Design & Manufacturing Quality

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Audits & Inspection Readiness

Prove internal and external quality readiness

Audits & Inspection Readiness

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Medical Device Process Validation

Validated processes slot into QMS SOPs and DHRs.

Process Validation Consulting

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Regulatory Consulting

Navigate the path to approval with Veranex.

Regulatory Consulting

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Outline your ISO 13485 roadmap, resource needs, and certification timeline

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