Medical Device Software Compliance

Are you confident that your medical device software meets all regulatory requirements and industry standards?

Our Medical Device Software Compliance service helps medical device and IVD companies ensure their software aligns with MDR, IVDR, FDA, ISO 13485, ISO 14971, IEC 62304, and IEC 82304. With tailored frameworks, expert guidance, and comprehensive technical documentation support, we simplify compliance so you can focus on innovation with confidence.

What is medical device software compliance?

Medical Device Software Compliance refers to the process of ensuring that software intended for use as a medical device, either on its own or in combination with other devices, adheres to relevant regulations such as the Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), or FDA requirements. To meet these regulatory needs, medical device software must be rigorously controlled, verified, and validated in accordance with applicable standards, including ISO 13485, ISO 14971, IEC 62304, and IEC 82304.

This process involves comprehensive support in developing the necessary framework and technical documentation to ensure full compliance. It is crucial for medical device and in vitro diagnostic companies whose products either incorporate or consist entirely of software to meet these standards to ensure safety, effectiveness, and market approval.

How we support you

With a tailored, pragmatic approach, we help you achieve full regulatory compliance.

Fully outsourcing the project to us for end-to-end support
Conducting a design study to identify potential areas for improvement
Coaching and supporting you in developing and implementing your validation strategy and approach
Implementing the strategy and approach you developed
Broadening the Quality Management System (QMS) to include software development
Helping to build or review the technical documentation of the medical device or in vitro diagnostic device

Why partner with QbD Group?

EXPERT TEAM WITH YEARS OF EXPERIENCE

Our approach emphasizes a lean and pragmatic framework that is tailored to your needs and working style, while also supporting the innovative nature of medical devices and in vitro diagnostics. With our broad knowledge and competencies, we are equipped to handle even the most recent technologies, such as AI and ML.

We enable you to choose the level of support you need, while also ensuring that you have access to the resources and expertise necessary to achieve regulatory compliance and deliver high-quality products.

Whether you need comprehensive validation support or targeted guidance in a specific area, our team is here to help.

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Have questions about Medical Device Software Compliance?

Our team is here to help. Fill out the form and one of our experts will reach out to discuss your specific needs and how we can support your compliance journey.

Medical Device Software Compliance

What is medical device software compliance?

How we support you

Why partner with QbD Group?

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