Reliability Evidence Report, 510(k)

Reliability Evidence Report

A European manufacturer of medical equipment was planning to bring products to the American market. They needed to demonstrate that the product, although it had been on the European market for many years, that it had a controlled reliability. This was done in a Reliability Evidence Report.

Requirements

Section 510(k) of the Food, Drug and Cosmetic Act, requires device manufacturers to notify FDA with what is known as Premarket Notification, or 510(k). A part of this 510(k) is Reliability Evidence. This includes CAPA analysis, theoretical prediction and life test of system and accelerated life test for components.

Execution

As part of the analysis of the system we performed or coordinated the following tasks:

  • Reliability Prediction of all electronics and mechanical parts
  • Reliability Block Diagram Analysis to establish a MTBF for the system including redundancies
  • Analysis of CAPA reports for the previous 5 years. The data was grouped and plotted using Weibull analysis to establish an MTBF value for the systems in use

Conclusions

The 510(k) Reliability Evidence Report was submitted in time and an interesting detail is that the MTBF from the Weibull analysis came very close to the value from the reliability prediction.