Regulatory Submissions

Coatings and Surface Modifications

IV Catheters

Syringes

Drug Delivery Devices

Implant Materials

  PHIL TRIOLO & ASSOCIATES  LC

   148 South 1200 East,    Salt Lake City, UT 84102 

(801) 328 1996 / (801) 328 2399 fax

SERVICES OFFERED

• Technical Assistance

• Selection,  Evaluation, and Regulatory Submissions for Biomaterials, Coatings, and Surface Treatments for Medical Products

• Project Management, integrating regulatory requirements with product development activities.

• Product Development

• Regulatory Compliance

• Preparation of 510k's, PMA's, IDE's, MAF's, and CE Mark Submissions

• Quality Manual Preparation (QSR, ISO), specializing in Design Control

•  Risk Analysis, Design Review

• Validation and Verification Protocol Implementation

• Technical Writing

• Labeling, Instructions for Use 

• Business Plans and SBIR Proposals