Driving Innovation Forward with Strategic Medical Device Quality Consulting

From QMS implementation to audit readiness, our quality experts prevent regulatory setbacks that delay patient access while accelerating market entry through integrated design validation and process excellence.

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Strategic Integration

Quality systems synchronized with product development, validation protocols, and regulatory pathways.

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Early Implementation

Robust quality frameworks established before design verification to capture risk effectively.

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Lean Scalability

Systems that support rapid iteration while maintaining manufacturing scale-up readiness.

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Comprehensive Coverage

ISO 13485 certification, design validation, process validation, and FDA inspection preparation.

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Design and Manufacturing Quality Services

V&V-ready design controls with complete traceability satisfying FDA, EU MDR, and ISO 13485 requirements.

Design and Manufacturing Quality Services

QMS Consulting

ISO 13485-compliant quality management systems that integrate seamlessly with product development, including rapid innovation cycles.

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Process Validation

Comprehensive IQ • OQ • PQ validation consulting. For any manufacturing, sterilization, packaging, and cleaning needs to prevent recalls and regulatory setbacks.

Process Validation

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Audit Readiness

FDA mock inspections, ISO 13485 gap assessments, and MDSAP preparation with proven 90-day readiness roadmaps.

Audit Readiness

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What Clients Say

"Our Veranex partners demonstrate exceptional flexibility, professionalism, and quality of service delivery, while most importantly bringing outstanding technical and human skills to every engagement."

COO, mid-size medtech company, Switzerland

What Clients Say

"Veranex has very well educated and knowledgeable staff who are very attentive to the details of the information provided along with the information they need to gather."

Regulatory Affairs Manager, large dental product manufacturer, US

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Naghmeh Nouri

Executive Director, Quality Engineering

Ramona Field

Executive Director, Quality Systems

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Jennie Sandström

Sr Director, Quality and Regulatory Affairs

Ready to Build Quality Excellence Into Your Medical Device?

Let’s work together on building and implementing quality systems that scale with your growth.

Contact our quality specialists