SaMD / Medical Device Software
Full MDSW lifecycle support
Medical device software manufacturers face complex classification, evolving standards, and increasing cybersecurity demands. QbD Group covers the full MDSW lifecycle — regulatory, quality, clinical, and design & development.
MDSW — development, compliance, and commercialization
Bringing medical device software to market is a multifaceted process that requires careful navigation through a rapidly changing landscape. Software plays a pivotal role in healthcare, enhancing diagnostics, personalized treatments, and patient monitoring.
To successfully commercialize, companies must understand market dynamics, including the needs of healthcare providers, payers, and patients, while aligning with regulatory requirements. Engaging key opinion leaders, demonstrating value through clinical data, and ensuring the software fits within national healthcare reimbursement systems are essential steps.
Ultimately, success lies in continuous evaluation and adaptation, ensuring the software meets evolving clinical and regulatory demands.
Key challenges we address
Complex risk classification
Under MDR and IVDR, risk classification of MDSW is relatively complex and in most cases results in a higher risk class compared to the old medical device directives. This, combined with the ever-changing state of the art, results in increasing regulatory, quality, and technical requirements.
Evolving standards
Manufacturers must follow IEC 62304, IEC 82304, ISO 14971, IEC 62366, and more — as well as various regulations such as the AI Act and GDPR, while always keeping cybersecurity at the forefront (ISO 81001).
AI & emerging regulations
New regulations like the AI Act and GDPR add layers of complexity alongside increasing cybersecurity demands. Medical device companies need to focus on technical, innovative, regulatory, quality, and clinical aspects simultaneously.
Connected ecosystem complexity
Devices are connected through IoT, smartphones, wearables, cloud servers, and sensors. Big data and AI further enhance capabilities while cybersecurity places additional high demands.
Our structured approach
Market launch strategies
Bringing medical device software to market is a multifaceted process that requires careful navigation through a rapidly changing landscape. Software plays a pivotal role in healthcare, enhancing diagnostics, personalized treatments, and patient monitoring.
Software development
The development of medical device software is a complex process, demanding strict adherence to international standards and regulatory requirements. Key standards like IEC 62304, IEC 62366, and ISO 14971 govern the software development life cycle, usability, and risk management.
Clinical integration
Incorporating clinical needs into medical device software design is essential for ensuring regulatory compliance and clinical effectiveness. This process begins with a robust clinical evaluation, as mandated by the Medical Device Regulation (MDR), requiring manufacturers to gather sufficient clinical evidence.
Technical documentation
Creating robust technical documentation (TD) is vital for compliance and market success in medical device software. The TD outlines critical information, from software qualification and classification to cybersecurity measures and product testing.
What you gain
Regulatory certainty
Clear pathways through complex MDSW classification and compliance requirements.
Faster time to market
Integrated support across regulatory, clinical, and technical domains accelerates market entry.
Future-proof compliance
Stay ahead of emerging regulations including AI Act, cybersecurity standards, and evolving MDR/IVDR requirements.
How we can help you
From qualification to post-market support, our experts guide you through every aspect of medical device software compliance.
MDSW Qualification & Classification
Guidance on qualifying and classifying your software as a medical device.
- Guidance on qualification and classification of SW as a Medical Device
- Support in defining regulatory pathways
MDSW Design & Development
Navigate IEC 62304 and ISO 14971 with confidence.
- IEC 62304 software lifecycle processes
- MD Design and Development principles
- Risk management ISO 14971
- Software validation — CSV
- IEC 82304-1:2016 — Health Software
- QA Support
Post-Market Support
Ongoing quality and compliance after market launch.
- QA Support
- Quality event management
- Inspections and audits
- Post-market surveillance (PMS)
- Post-market clinical follow-up (PMCF)
QMS — ISO 13485:2016
Tailored quality management system implementation.
- Quality Management System implementation tailored to your needs
- Audits — Audit preparation
- ISO 13485:2016 Training
Regulatory Affairs & Clinical Solutions
End-to-end regulatory and clinical support for MDSW.
- Technical documentation filing support
- MDR/IVDR regulatory pathway
- Clinical evaluation and investigations
- Tailored MDR — IVDR training
Cybersecurity & AI
Stay ahead of emerging security and AI regulations.
- ISO 81001 cybersecurity standards
- AI Act compliance
- GDPR alignment
- Risk-based security assessments
FAQ
Frequently asked questions
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Need support with medical device software?
Get in touch with our MDSW experts for tailored regulatory, quality, and development support.