Medical Device Design Verification & Validation | Veranex

Design Controls Done Right: Compliant to ISO 13485, FDA and MDR Requirements

Our quality experts integrate seamlessly with your development team or with our own Product Design & Engineering group. Together we map device design inputs, including those from risk management, execute design validation and verification, and curate a robust Design History File or Technical File that streamlines the overall review process with regulators. We monitor standards updates, pinpoint gaps, and deploy rapid remediation to maintain audit-ready compliance.

Product Design & Engineering Services

Innovation & Compliance

Veranex bridges innovation and compliance, empowering device companies to move confidently from concept to commercialization with proven regulatory strategies and quality systems that stand up to global scrutiny.

V&V Readiness with Scalable Manufacturing Quality

As an Innovation CRO (iCRO), Veranex synchronizes Design & Manufacturing Quality with upstream engineering and downstream regulatory paths, ensuring design verification and validation are seamlessly integrated within the full concept-to-commercialization journey.

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A robust design-control process runs from user needs through validation with documented design reviews, tollgates, and full requirements traceability.

Veranex unites QA, RA, and engineering along that path, ensuring every file aligns with ISO 13485, FDA QMSR, EU MDR, and applicable MDCG guidance.

Services provided:

End-to-end V&V strategy & execution
Gap assessments per FDA, IEC 60601, IEC 62366, and EU MDCG
Design input to design output tracing (for design, process, and usability)
Biocompatibility and cleaning sterilization validations
Reusable-device cleaning and reprocessing studies
Software & cybersecurity design-input consulting
FDA product-specific guidance and EU dossier alignment

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Documentation gaps force costly redesigns and trigger audit findings.

Veranex cultivates a robust Design History File and Technical File that withstand regulatory scrutiny by FDA, EU MDR, and MDSAP inspections without critical findings. Helping clients revise and maintain design documentation avoids re-work, late device-testing gaps, and commercialization delays for continuous success.

Services provided:

DHF / DMR and Technical File authorizations and curations
Continuous standards monitoring with gap remediations (IEC 60601, IEC 62366, EU MDCG, & FDA guidance)
Collaboration workflows including design reviews, requirements traceability, and eQMS integration that turn documentation into a design accelerator

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A process validation missteps during scale-up can derail manufacturing transfer and delay commercialization.

Veranex’s experienced medical device process validation teams deliver first-pass approvals by aligning protocols with FDA, EU-MDR, and MDSAP requirements for successful results. Teams are integrated from design phases through manufacturing to ensure design transfer is efficient and successful, being to our facilities or yours.

Services provided:

IQ / OQ / PQ process validation protocol development and execution
Packaging, cleaning and sterility validation to FDA & EU expectations (for complex EO, steam, or gamma cycles)
Effective design and manufacturing-site transfers

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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

Stephany Esa, MSc.

Director, Design Assurance Engineering

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Building FDA-Ready Quality Infrastructure

Situation

An innovative medical device startup had developed a breakthrough therapeutic device with significant market potential but lacked the quality infrastructure and regulatory expertise needed for successful market entry.

They had already engaged a contract manufacturer but realized they needed comprehensive quality oversight to ensure their development activities would meet FDA and EU MDR requirements.

Successes

Veranex implemented a comprehensive quality framework that resulted in a complete, submission-ready Medical Device File.

Services by Veranex

ISO 13485 QMS launch – lean system sized for a startup
Integrated ISO 14971 risk files tied to design controls
End-to-end V&V & process validation plan and execution
Supplier / CM oversight – quality agreements, audits, qualifications
Reg-ready DHF & EU MDR Tech File for submission
Team enablement & internal audits to embed a sustainable quality culture

Quality Management Systems

ISO 13485 QMS locks quality early, pre-empting audit findings and accelerating every launch milestone.

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Audits & Inspection Readiness

Mock audits expose gaps now, preventing 483s and costly post-submission delays.

Readiness Services

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Special Process Validation

First pass validation secure scale-up without production rework for any manufacturing, sterilization, or packaging processes.

Process Validation Services

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Design with Risk Mitigation & Cybersecurity

ISO 14971 risk and cyber controls avert recalls while safeguarding patient data, keep these design requirements at the forefront of development for a successful device.

Software Development

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Book Your 30-Minute Validation Speed Audit Consultation

Discover how our V&V playbook compresses test loops, eliminates documentation rework, and positions your submission for first-pass approval.

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