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

Medical Product Development

Experience     

 The best way to learn how to do something is to          just do it.  Sounds Simple, but it usually isn't.  Experience.  Book learning can make experiences more pleasant, but it can't replace experience as a teacher.

Phil Triolo and Associates has hands-on experience developing the following:

• Coatings for Intravascular Catheters
• Short and Long-term Intravascular Catheters
• Drug Delivery Devices, including Portable Infusion Pumps
• Polymeric Test Tubes to replace glass tubes
• Nerve and Tracheal Prostheses
• Needle-free Access Devices

Let us use our experience to help you select a suitable biomaterial or coating to improve biocompatibility or antimicrobial properties of your implant, develop a cardiovascular or drug delivery device, or develop an in vitro diagnostic product.

Design Control

With the introduction of Design Control requirements in the Quality System Regulation, a systematic approach to design is no longer merely logical; it is a legal obligation for marketing medical products in the United States. Companies that efficiently incorporate Design Control procedures that complement rather than impede developmental efforts have a distinct advantage in the highly competitive medical product marketplace.

Rather than impose 'cookbook' documentation requirements on the developmental process,  Phil Triolo and Associates work with your development team to understand the processes unique to your organization, and then develop Design Control procedures that reflect actual development activities.  This places as little burden as possible on the development team while assuring that all facets of development are appropriately reviewed and documented as part of the Design History File (and Technical Files or Design Dossiers for CE marking).