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Regulatory submissions, although primarily technical documents reviewed by technical personnel, are also marketing and educational documents. Submissions need to educate overworked
reviewers about the subtle complexities of your new products. They must also convince reviewers that these products are safe and effective while conveying the competence of your organization. The professional,
well-organized and concisely written submissions prepared by Phil Triolo and Associates assure short FDA approval times, clearing the way for rapid product introductions. Phil Triolo has authored submission
for the following devices. All of these products have been cleared by the FDA in times significantly shorter than average:
- Short- and Long-term Intravascular Catheters
- Embolectomy Catheters
- Needle-Free Access Devices
- Reusable Pressure Transducers
- High-pressure Syringes
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To receive a quote on the preparation of a 510(k), Premarket Approval, or CE Mark submission, or on the preparation of any portion of these or a Device Master File, please contact Phil Triolo. |
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