Clinical Studies
Sample CRF
- A CRF used in a clinical study to evaluate the safety and effectiveness of MRI-guided breast biopsy tools (Size: 856k)
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Quality: Now™
Sample SOPs and FORMs
- SOP: FDA Inspections and FORM: FDA Inspections Reporting (Size: 1.3M) >>>
- FORM: FDA Inspections Reporting (Size: 661k) >>>
- SOP: Deciding Whether to Submit a 510(k) Submission (Size: 784k) >>>
- FORM: 510(k) Decision Tree (Size: 712k) >>>
White Papers
Design Controls
- DESIGN CONTROLS: Small and start-up medical device companies need to be compliant with the FDA quality system regulations (QSR)
(Size: 120k) >>>
MRI Compatibility
NEMA MRI 510(k) templates
- Standardized 510(k) pre-market notification submission template for RF coil accessories intended for use with magnetic
resonance diagnostic imaging devices (Size: 40k) >>>
- Standardized 510(k) pre-market notification submission template for software intended for use with magnetic resonance
diagnostic imaging devices (Size: 32k) >>>
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