Medical Device Development Process
A PROVEN PROCESS OF MEDICAL DEVICE DEVELOPMENT
A senior team with over 100 man years of experience in medical device development, Tronics MedTech has established a proven product development process. Our flexible staged approach can be adapted to a client's unique needs.
Product Concept
IP Legal Assessment · Development Strategy · Manufacturing Strategy · Marketing Goals ·
Clinical/Regulatory Strategy
Feasibility
Prototype Design Specifications & Review · Human Factors Plan · Preliminary Manufacturing & QA Plans · Preliminary Design Assurance Plans · Initial Hazard Analysis · Prototype Build & Test · Regulatory Review · Preclinical Trials
Development
Product Development · Critical Design Reviews · Design Verification · Design Transfer Plan · Regulatory Review · Customer Assessment
Evaluation
Product and System Qualification Reports · Design Transfer Report · Service Plan · Regulatory Submissions · Clinical Trials · Clinical Study Report
Market Release
Field Technical Support · Regulatory Approvals — FDA & OUS · First Article Inspection · Product Release Authorization · Post–market Trials