IMSCC Resource Library
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- Biologics/IVD 17
- Clinical Trial Guidance 29
- Laboratory 7
- Medical Device 17
- Medical Device and Biologics/IVD 2
- Medical Device and Software 1
- Quality System 19
- Regulatory Submissions 63
- Software 8
- Software and Regulatory 1
- Software and Regulatory Submissions 2
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- 510k 17
- Adverse Events 3
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- Biologics/IVD 25
- Breakthrough Devices Program 1
- Clinical Trial 32
- Combination Product 1
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- Drug 7
- FDA Fees 5
- Human Factors 1
- Investigational Device Exemption (IDE) 3
- Labeling 16
- Laboratory 6
- Machine Learning/Artificaial Intelligance 1
- Manufacturing 7
- Pediatrics 4
- Performance Testing 3
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- Post-Market Studies 4
- Pre-Clinical Studies: Regulatory Submission 1
- Premarket Approval Application 14
- Quality System 20
- Recalls 1
- Regulatory Inspection 2
- Regulatory Submission 70
- Risk Management 21
- Software 13
- User Fees 1
- Validation 4
Other Resources
Click here to access a comprehensive and open access database, curated by Sepsis Alliance, of scholarly articles, patents, and other academic resources related to sepsis diagnostics. Our aim is to make innovation more accessible and inclusive by offering a resource for researchers, innovators, and other stakeholders to explore scientific trends, understand the intellectual property landscape, and identify new research opportunities.