Medical Device Software Compliance
Ensure your software meets MDR, IVDR, FDA, and ISO 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 and expert guidance, we simplify compliance.
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.
Full outsourcing
Fully outsourcing the project to us for end-to-end support.
Design study
Conducting a design study to identify potential areas for improvement.
Coaching and support
Coaching and supporting you in developing and implementing your validation strategy and approach.
Implementation
Implementing the strategy and approach you developed.
QMS broadening
Broadening the Quality Management System (QMS) to include software development.
Technical documentation
Helping to build or review the technical documentation of the medical device or in vitro diagnostic device.
Why QbD Group
Your trusted partner
Our approach emphasizes a lean and pragmatic framework tailored to your needs:
Lean and pragmatic framework
tailored to your needs and working style, while supporting the innovative nature of medical devices and in vitro diagnostics.
Broad knowledge and competencies
equipped to handle even the most recent technologies, such as AI and ML.
Flexible support levels
choose the level of support you need, from comprehensive validation to targeted guidance. Whether you need comprehensive validation support or targeted guidance in a specific area, our team is here to help.
Regulatory expertise
deep knowledge of MDR, IVDR, FDA, ISO 13485, ISO 14971, IEC 62304, and IEC 82304.
Let's talk Software
From system validation to digital transformation, our software experts are ready to support your journey.