CE Marking for Medical Devices (MDR & IVDR)

Enter the European market with CE Marking for your software

“Is your software qualified as a medical device? What is its classification under the MDR/IVDR?

Benefits of CE Marking

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EU Market Access

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Trust & Credibility

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Strategic Advantage

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Rely on a team with proven experience implementing software lifecycle activities and preparing technical documentation. We guide you from day one to ensure your medical device software complies with the regulations efficiently, safely, and without surprises.

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Why SQS?

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Expertise in Medical Devices SW

Over 20 years of experience supporting healthcare companies back us up.

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Process implementation

We embed IEC 62304 from day one of the software lifecycle.

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360° perspective on regulation and technology

We combine standards, risk management, and agile delivery to keep your project moving smoothly.

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Mastery of key standards

IEC 62304, ISO 14971, IEC 82304-1, IEC 60601-1, IEC 81001-5-1… all fully embedded into our processes.

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End-to-end support, from idea to audit

We don’t just assess—you get guidance at every stage to reach CE marking with confidence.

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Real partnership, not just consulting

We join communications with Notified Bodies and participate in audits.

Got questions? We’re here to help.

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Certificaciones

ISO 9001

ISO/IEC 27001

ENS-nivel medio

ISO 20000

UNE-EN ISO/IEC 17025