Welcome back to Morris Medical Monthly: a monthly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will start on the subject of Polarion’s RiskPack extension, and have a look how to use Riskpack.

This section explains how to start a risk management project from scratch. You should have read the RiskPack Basics section before reading this section.

General: The risk management process

Risk management generally consists of four major steps:

Risk management planning

• Define your risk policy, i.e. set the categories for the severity of harm and the probability of occurence


• Define the acceptance levels for all risk/probability-combinations


• Define the risk management process


• Define the risk management team

Risk analysis

Analyse how the product under consideration can lead to harm to patients, operators or other persons or to
property or the environment.

Risk estimation and evaluation

Decide on the severity and probabilty of the harms that can occur
Decide whether the risk is acceptable or must be mitigated

Risk control

Decide on risk control measures for risks rated as unacceptable
Track the implementation, verification and check for effectiveness of these risk control measures
Except for basic planning steps, there is no need to finish one of these activities before the next one can be started.
Therefore, the RiskPack allows to perform these steps in any order and at any time.

For more information about Polarion’s RiskPack visit our Extension Portal using following link:

http://extensions.polarion.com/extensions/184-polarion-alm-riskpack-iso-14971. I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monthly article.