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| Decus Gets Results!
510(k)s, PMAs, CE Mark, Canadian Approvals
- Medical Image Analyzer (Mammography CAD)
- Image Processing Software
- Vital Sign Networking and Communication Software
- Ophthalmic Ultrasound
- Cranial Electrotherapy Stimulator
- Nystagmograph
- Electroencephalogram
- RF Devices
- Particular expertise in software documentation
Clinical Trials
- Multi-site trials for Class III and Class II devices
- Mammography Computer Aided Detection Studies
- Pain Treatment Studies
- UV Treatment Studies
- FDA BIMO inspections – no observations
- Pre-IDE meetings with FDA
- Experienced with all aspects of preparation, execution, and reporting of clinical trials
- ANOVA and Factorial Designs
- Sensitivity and Specificity Studies
- Reader Performance Studies
- Double-blind, Randomized Control Treatment Studies
Quality Systems
- Establish Quality Systems
- EEG Device Manufacturer
- Image Database Mining Software Development Company
- Mammography Computer Aided Detection Company
- Ultrasound Company
- Light Therapy Company
- Internal quality system audits to US, Canadian, and ISO standards and regulations including:
- IEC 62304
- ISO 14971
- Usability and Human Factors Standards
- Conduct GLP and GCP audits
- FDA Pre-approval and BIMO inspections
- Notified Body ISO 13485:2003 and CMDCAS inspections
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