risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 18.05.2012 FDA notification, CE-marking, EN 1441 Qware Riskmanager
risk-analysis, DIN 14971, risk-management, medical-devices
seminars software market analysis accomodation certification notified body product lifecyclerisk management report Risk analysis of medical devices DIN EN ISO 14971
admission of medical products implementation of risk management for medical devices harmonized normQware Riskmanager
ISO 9000 implementing of a Risk analysis risk control
post production information implementation of risk management according to DIN EN 14971- Medica 2011
post production information implementation of risk management according to DIN EN 14971- Advantages
risk management versus Risk analysis documentation- Screenshots
seminars post production information risk management report- Trial Version
DIN EN ISO 14971 In-Vitro-Diagnostics CE-marking- Full version
FDA authorization CE-marking- Download
Qware Riskmanager- Purchase
product lifecycleRisk analysis of medical devices post production information- FAQ
harmonized norm DIN EN 14971
accomodation certification notified bodyReferences
implementation of a risk analysis risk management normative law regulations
Likelihood and severity evaluation after measuresPartner
DIN EN ISO 14971:2000
assignment with DIN EN ISO 13485_2003Articles | Reports | News
product process severity measures evaluation likelihood
life cycle time line implement system requirements practical applicationService
directive 93/42/EWG risk evaluation and for risk control
New functions in Qware Riskmanager 4.0
Visit us at the Medica 2011
In-Vitro-Diagnostics IVD FDA authorization CE-marking

Qware Riskmanger 4.0 Live presentation at Medica 2011

Qware Riskmanager In-Vitro-Diagnostika Medica 2011
Regualtory Affairs Wahrscheinlichkeit des Auftretens eines Schadens  Medica 2011

Riskmanager 4.0 at Medica 2011

At Medica 2011 we are pleased to present the new version 4.0 of Qware Riskmanager which was continuously developed from scratch over a time period of 12 years. The Risk Manager is the world's leading software product for risk management according to DIN EN 14971

User Interface Design GmbH In cooperation with the User Interface Design GmbH the Riskmanager has been extended to the usability engineering in accordance with IEC EN 60601-1-6/EN62366 In addition to that Riskmanager 4.0 supports not only the classical risk analysis but also the FMEA according to DIN EN 60812 now.

We are glad to show you all new features in a fully functional and equipped with many sample data environment on our Medica booth (Hall 15 Stand C14) You have the chance to become acquainted with the software with its new benefits and convince yourself of the functionality and usability.

Discuss all your questions around the topic of risk management according to DIN EN ISO 14971 and management of the usability according to IEC EN 60601-1-6/EN62366 Get free advices on how to optimize the approval process within the framework of the CE marking in your company.

The first 50 registrations for a preliminary appointment at the Medica 2011 will get an interactive loose-leaf collection for the health service MEDiLEX as a THANK YOU.

Preliminary appointment

Appointment *
Record of topics

I would like to be informed about the following:
Salutation *
Title
First name *
Last name *
Company *
Street *
Postal code *
City *
Country
Email *
Website
Phone
 
Fields marked by * are mandatory.
Medica 2011
Qware Riskmanager 4.0
Qware Riskmanager 4.0
The market leading software solution for the riskmanagement of medical devices and in-vitro-diagnostics is completely revised.
Read more about the new functions of Qware Riskmanager 4.0
15 years MEDiLEX
The market leader in interactive loose-leaf collections of European legislation on medical devices and in-vitro diagnostics celebrates birthday! Of course that you should benefit from this.
Find out more!
top of page