risk-analysis, DIN 14971, risk-management, medical-devices
Risko analysis, DIN 14971, Risk management Medical devices, In-Vitro-Diagnostics, IVD DEUTSCH | IMPRINT 13.05.2008 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
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
post production information implementation of risk management according to DIN EN 14971- Support & Updates
risk management versus Risk analysis documentation- Download Updates
seminars post production information risk management report- Trainings
directive 93/42/EWG risk evaluation and for risk control
New functions in Qware Riskmanager 2.5
In-Vitro-Diagnostics IVD FDA authorization CE-marking

Service for risk management according to DIN EN ISO 14971

product lifecycleQware Riskmanager In-Vitro-Diagnostics Medizinprodukte
Regualtory Affairs likelihood of appearing a damage  FAQ

Product support & updates

To adapt Qware Riskmanager to future technical and legal requirements, the software will be improved continually.
Registered users with a valid maintenance contract can download the latest updates and patches from this website under the menu topic "Service / Download Updates".

Additional services

To facilitate the introduction in the work with Qware Riskmanager and the DIN EN ISO 14971 we offer training and consulting services. From software trainings for engineers up to complex workshops to develop a complete risk management for your products, bayoonet will support you state-of-the-art with top-skilled consultants.
Screenshots Qware Riskmanager
Here you get an overview of frequently asked questions. Please check this site first, before you start a request for support.
Partner
Screenshots Qware Riskmanager
Here you find the appropriate partner to implement your risk management system.
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