CE Marking for Medical Devices (MDR & IVDR)

Enter the European market with CE Marking for your software

Do you develop healthcare software and need to market it in Europe? CE Marking is mandatory both for medical device software (MDR) and for in vitro diagnostic software (IVDR). We help you certify your software in compliance with European regulations, with a technical, agile, and digital-first approach.

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Benefits of CE Marking

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Avoid legal blocks and penalties

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Ensure quality and reliability

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Build the foundation for further certifications such as ISO, MDR, and IVDR

Request a Risk Assessment

Depending on the type of software and its risk, we guide you throughout the entire process of preparing and submitting the Technical Documentation under MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) — from identifying requirements to obtaining certification through your Notified Body.

MDR & IVDR Assessment

Why SQS?

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Expertise in medical devices

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

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Avoid rework in development

We integrate IEC 62304 from the start of the lifecycle.

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Support with documentation and reports

Choose your preferred service platform: on-premise, virtualization, or cloud.

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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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Confidence to scale or tender

We deliver documentation ready for audits or investors.

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Real support, not just consulting

We actively participate in documentation and in interactions with Notified Bodies.

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