risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 08.12.2019 FDA notification, CE-marking, EN 1441 Qware® Riskmanager
risk-analysis, DIN 14971, risk-management, medical-devices
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DIN EN ISO 14971 In-Vitro-Diagnostics CE-marking
FDA authorization CE-marking
Qware® Riskmanager
product lifecycleRisk analysis of medical devices post production information
harmonized norm DIN EN 14971
accomodation certification notified body
 implementation of a risk analysis risk management normative law regulations
Likelihood and severity evaluation after measures
DIN EN ISO 14971:2000
assignment with DIN EN ISO 13485_2003
product process severity measures evaluation likelihood
life cycle time line implement system requirements  practical application
 directive 93/42/EWG risk evaluation and for risk control
New functions in Qware® Riskmanager
In-Vitro-Diagnostics IVD FDA authorization CE-marking

Riskmanagement according to DIN EN ISO 14971

Regualtory Affairs likelihood of appearing a damage  Qware® Riskmanager

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 Comparison".

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 more efficient.
If you are interested please send us an email to sales@bayoo.net.

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 14971.

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
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.

Please find a trial version of Qware® Riskmanager here.

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 company.
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® LiveSync
  • 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® and Excel®)
  • 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.
 8.4.0
Qware® Riskmanager
A new version of the market-leading software solution for generating technical documentation for medical devices and in-vitro-diagnostics has been released.
Read more about the new functions of Qware® Riskmanager
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