RESOURCES
Your go-to library for practical, easy-to-use guidance on the topics that matter most in medical device development.
Updated regularly by our industry experts to help you work smarter across quality, regulation, clinical work, and software.
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See the medical device articles shaping conversations now, from risk and design to software and quality.
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Dive into our clearest visual explainers on SaMD,
risk management, quality, and other core device
topics.
Templates
Get proven, ready-to-use tools for medical device work – from quality manuals to design plans and to CAPA forms.
All resources
Software for medical devices: What stakeholders expect
Medical Device Requirements Overview (E-book)
Agile development practices: What ‘done’ and ‘ready’ really mean
Installation Qualification (IQ) Protocol Template (Medical Device)
Operational Qualification (OQ) Protocol Template (Medical Device)
Performance Qualification (PQ) Protocol Template (Medical Device)
Audit Plan Template (ISO 13485, Medical Device)
Medical Device HQ on YouTube
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Popular right now
Software for medical devices: What stakeholders expect
Agile development practices: What ‘done’ and ‘ready’ really mean
Illustrated guides
Software for medical devices: What stakeholders expect
Agile development practices: What ‘done’ and ‘ready’ really mean
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- Topics include:
- 21 CFR Part 820
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- EUDAMED
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- IEC 60601-1
- IEC 62304
- IEC 62366-1
- Intended use
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- ISO 13485
- ISO 14155
- ISO 14971
- ISO 19011
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