Integrated Risk Management - 4 standards in one solution
New version 7.0 released!
The new version 7.0 of Qware® Riskmanager facilitates the creation
of your technical documentation while fulfilling the requirements of 21 CFR
Part 11. The new functions Audit Trail, Digital Signature and Password
Policy are since version 7.0 part of the base module of Qware®
Riskmanager. While the audit trail is activated, all changes of data by the
users of Qware® Riskmanager are logged. The logged changes can be
examined and exported in the administration area. Furthermore, certificates can
be stored and used by authorized users to export reports as digitally signed
PDF documents. With the new password policy features, Qware® Riskmanager
allows you to secure your data more reliably from unauthorized access. Along
with the new functionalities representing the demands of 21 CFR Part 11, the
performance while deciding about the implementation of measures was greatly
improved, as was the amount of examined data in the program part "Version
Next dates for the Qware® Riskmanager live webinar:
16th March 2016, 10:30 a.m. - 12:00 p.m. (Focus: FMEA)
23rd March 2016, 10:30 a.m. - 12:00 p.m.
24th March 2016, 12:30 p.m. - 02:00 p.m. (Presentation language: English)
6th April 2016, 10:30 a.m. - 12:00 p.m.
13th April 2016, 10:30 a.m. - 12:00 p.m. (Focus: FMEA)
27th April 2016, 10:30 a.m. - 12:00 p.m. (Focus: IEC 80001-1)
28th April 2016, 12:00 p.m. - 13:30 p.m. (Presentation language: English)
04th May 2016, 10:30 a.m. - 12:00 p.m.
11th May 2016, 10:30 a.m. - 12:00 p.m. (Focus: FMEA)
18th May 2016, 10:30 a.m. - 12:00 p.m.
24th May 2016, 12:00 p.m. - 13:30 p.m. (Presentation language: English)
25th May 2016, 12:00 p.m. - 13:30 p.m. (Focus: IEC 80001-1)
01st June 2016, 10:30 a.m. - 12:00 p.m. (Focus: FMEA)
15th June 2016, 10:30 a.m. - 12:00 p.m.
22nd June 2016, 10:30 a.m. - 12:00 p.m.
29th June 2016, 10:30 a.m. - 12:00 p.m. (Focus: IEC 80001-1)
Let us present you the possibilities of Qware® Riskmanager very
comfortable at your workplace. Our experts will answer any questions and show
you all the functions that make the generation of your technical documentation
If you are interested please send us an email to firstname.lastname@example.org.
DIN EN ISO 14971:2012
Since software version 4.6 you can document your risk management according to
the requirements of the new ISO 14971:2012, which is valid since August
2012 without transition period. Since version 6.0 Qware® Risk
Manager offers the possibility to manage requirements systematically.
Requirements are fully integrated into the risk management process according to ISO
IEC EN 60601-1, 3rd edition
Another new feature of version 5.0 is the integration of the requirements in
accordance to IEC EN 60601-1 (3rd Edition) with the additional module
"Medical Electrical Equipment". Find out more about the advantages of the
checklist based creation of conformity reports. The IEC EN 60601-1 is
completely integrated into the risk management according to ISO 14971.
IEC 60601-1-6 / EN 62366
The usability engineering file according to IEC 60601-1-6 and EN 62366 can be
created hand in hand with the documentation of the risk management file
according to ISO 14971. This full integration will save your time and helps to
avoid redundant data.
93/42/EEC Annex I - 2007/74/EC
Please find a trial version of Qware® Riskmanager
Since Qware® Riskmanager version 5.1, the new module "Essential
Requirements" assists in proving and documenting the essential requirements in
accordance with MDD 93/42/EEC (2007/74/EC) and IVDD 98/79/EC by an intelligent
question mechanism. Like all expansion modules the "Essential Requirements"
module is fully integrated into the risk management module.
Successfully in the market for over 14 years
As a ready-to-use, inexpensive and established system, Qware® Riskmanager
accelerates the development and certification process of your medical devices.
You devote your time to the contents instead of how they are presented. Qware®
Riskmanager helps to identify and visualize risks and how they are distributed
during early lifecycle phases. Its intuitive user interface, database of sample
projects and full documentation make it the ideal tool for beginners. Its
auto-updating knowledge database leads to profitable synergy effects between
projects - and helps to make the knowledge and insight available throughout the
Since 2000 Qware® Riskmanager has been continually upgraded to
comply with changes to regulatory requirements. Its range of features expanded
to remain continuously at the top of the league.
Professional Risk Management with Qware® Riskmanager
Generates comprehensive risk management file in accordance with ISO 14971
Parallel creation of usability engineering files in accordance with IEC
60601-1-6 / EN 62366
Risk analysis of products, components and processes with before/ after
comparison and evaluation of the residual risk
Choice of risk analysis method
Bottom-Up in accordance with FMEA (EN IEC 60812)
Top-Down is derived from Preliminary Hazard Analysis - PHA
Fine-grained configuration of authorization administration
Validation and verification of implemented measures
Implementation of risk management review with automatic reminder feature
Graphic grey-box analysis feature
Integrated document management and auto-updating knowledge database
All data logged in company-specific standard types and definitions
Real time multi-user operation via Qware®
Intuitive, multi-lingual interface
Automatic suggestion feature e.g. to identify the most effective measures
Ensuring an audit-proof documentation of all measures (traceability)
Risk management file, conformity reports in accordance with IEC 60601-1, and
usability engineering files to print or export (i.e. as PDF, Microsoft Word®
Graphic design feature for your documents' contents and layout
Ask for a free of charge Trial Version of
Qware® Riskmanager without any obligation. You can get Qware®
Riskmanager via CD-Rom
or you can download the
Trial Version directly from this homepage.