Medical Devices

At SQS, we work to help companies in the healthcare sector in an agile manner.

We have more than 15 years of experience in this sector, working for both the FDA and European regulations. We help companies with activities within the CE and FDA marking, validation and verification activities, as well as cybersecurity for medical device software, following the applicable regulations and standards.

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CE Marking Medical Device Software

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

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Verification and Validation Services

Ensure the quality of your medical devices with independent verification and validation.

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Cybersecurity Services

Protect your medical devices with our specialized cybersecurity services. We offer full implementation of the IEC 81001-5-1 standard, expert consulting for compliance with cybersecurity requirements throughout the product lifecycle, and pentesting designed specifically to identify technical and operational vulnerabilities. Ensure regulatory compliance, mitigate risks, and strengthen confidence in your medical devices from design to use in the clinical environment.

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Artificial Intelligence

Innovate or update your medical devices with our specialized artificial intelligence services. We advise you throughout every stage of your medical device’s life cycle.

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Quality and Safety Management

We support you in implementing your quality management system, software lifecycle, and security management.

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Training Services

We provide specialized training in the development and regulation of software as a medical device (SaMD), focusing on the requirements of the MDR/IVDR and FDA regulations, the IEC 62304 and IEC14971 standards, and other applicable guidelines. Our courses are designed for technical and quality teams who need to gain an in-depth understanding of the regulatory framework, software classification, technical documentation, and validation and verification requirements, ensuring compliance from the initial design stages through to commercialization.

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