The medical device regulatory intelligence and strategy process

By Marcelo Antunes on November 17, 2020

We present here the format of the new #service from SQR Consulting.

First of all, part 6 is out of scope and is presented for contextual purposes.

The process is active, but varies in scope, between the “a” and “b” sides.

1b and 2b are related to monitoring and obtaining data from pre-defined regulatory sources.

1a and 2a is the directed regulatory research pathway, to develop answers to specific regulatory questions, whose data are retrieved in a more closed scope and with more details.

In part 3, the retrieved data are appraised in terms of aspects such as quality, validity and weight in a specific context, in order to conclude about the SIGNIFICANCE of these data. Each SIGNIFICANT data about the object becomes # information.

Part 4 concerns the CRITICAL ANALYSIS of information, which leads to DISCOVERIES, about which actions can be taken.

Part 5 concerns the interpretation of the findings considering the #business. This part is not entirely contemplated by RI.

Published in Regulatory Intelligence, Regulatory intelligence and strategy for medical devices Series and Regulatory Strategy