Phil Triolo

Background

About Phil Triolo

I work with both small and virtual start-up companies to devise regulatory strategies to launch their products as quickly as possible in the US, EU, and Canada, as well as large multinational companies to assist them in meeting new, or changed requirements; or to provide support when extra resources are needed. Product Specialty Areas range from implants, cardiovascular, drug delivery, and blood access devices and combination products to innovative wellness devices that will evolve into medical devices with disease-specific claims, active implantable medical devices, software, and video games used as therapeutic devices. In short, my experience in medical product development and education as a biomedical engineer allow me to understand the underlying technology for a wide array of medical devices. This understanding forms the basis for a strong regulatory position because, in the end, the reviewers of your regulatory applications will focus on technical information and data demonstrating the safety and performance of your device by officials competent in your technology as well as regulatory requirements. Regulatory Specialties: Regulatory Submissions and Strategies for Launching Medical Devices and Combination Products in multiple markets Pre-Submission Meetings (513(gs), Q Subs,); Requests for Designation Clinical Evaluation Reports, Risk Management Reports, Reports of Prior Investigations (RPIs) 510k, de Novo, PMA Submissions, CE Marking, CMDCAS Licenses Shelf Life Validation (Including packaging, accelerated aging, simulated shipping and storage) Design Controls/ Independent Reviewer at Design (Phase) Reviews Quality System (QSR, ISO 13485) Auditing and Implementation Biocompatibility Evaluation and Toxicological Risk Assessments Health Canada and US Agent Services, including Drug and Device Registration and Listing DMF Preparation and Maintenance - FDA, Canadian in eCTD format eCopy Preparation eMDR and Vigilance Reporting Responses to 483s