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Quick Tour Slide Show and Trial Software
Risk Analysis, Evaluation, and Control
ISOXpress 14971 Medical Device Risk Management software is a Windows application
for implementing Risk Analysis, Risk Evaluation, and Risk Control in strict compliance
with the ISO 14971:2012 standard.
- Risk analysis, risk evaluation, and risk control methodologies
strictly follow requirements of ISO 14971 and all recommendations included in ISO
14971 Annex B through E.
- Reports generated by ISOXpress comply
with ISO 14971 requirements for Risk Management File (Clause 3.5) and provide most
of the content required for that file.
Risk Study is Developed in Seven Steps:
- STEP 1: Identify
the medical device and the scope of the risk study
- STEP
2: Define the risk matrix for the study
- STEP
3: Establish a list of generic hazards that may apply to the medical device
- STEP
4: Consider uses and characteristics related to the safety of the medical
device, and the associated risk factors and hazards
- STEP
5: Conduct risk analysis and risk evaluation: define hazards, hazardous situations
and harms to be included in the risk analysis, and estimate the associated probabilities,
severities and risks
- STEP
6: Investigate unacceptable risks and define/implement risk control measures
to reduce these risks
- STEP
7: Generate and publish (approve and release) the Risk Study Report (PDF)
Instructions and Tutorials
There is a comprehensive tutorial included with the software. It explains all the
stages (steps) of developing a risk study, and the tools and techniques available
in the software for implementing the study.
The tutorial consists of several slide shows with screen shots of the software and
(yellow) balloons providing the narrative. The slide show format is the easiest
and most efficient way to learn how to develop the risk study and how to use the
software.
The following slide shows are available in the tutorial:
- Risk Study Overview
- Risk Matrix
- Generic Hazards
- Uses and Safety Characteristics
- Risk Analysis
- Risk Control
- Reports
Risk studies are saved in files and/or templates
Risk management studies are saved in into .rsk files -- just as documents are saved
as .doc/.docx files in MS Word.
Risk studies can also be saved as templates. These can be blank studies with pre-defined
risk matrix, generic hazards, safety characteristics, etc.
ISOXpress ships with a template that includes generic hazards and generic safety
characteristics.
Customizable PDF Reports
PDF Reports generated by ISOXpress comply with ISO 14971 requirements for Risk Management
File (Clause 3.5); and provide most of the content required for that file. There
is even an approval signature page, so that the report is ready for publishing as
a controlled document and/or for submitting the study to your regulatory agency.
A full report includes the following sections:
- Title Page
- Table of Contents
- General Information
- Approvals (signature page)
- Risk Matrix
- Risk Study Summary Report
- Risk Study Detailed Report
- Appendix 1 - Generic Hazards
- Appendix 2 - Considered Uses and Safety
Characteristics
The reports are highly customizable:
- There is an integrated editor to help you compose a
header including company logo, background image, and additional lines of formatted
text
- Every caption in the report can be
edited, allowing you to customize the report template, and even translate the template
into any language
- You can choose which sections to include
in the report
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