Solution
The Validated Approval Accelerator
Risk Management According to ISO 14971
Usability Engineering According to EN 62366
Essential Requirements According to MDR 2017/745 & IVDR 2017/746
Conformity Report for Medical Electrical Equipment According to EN 60601-1
Risk Management for IT Networks According to IEC 80001-1
Process Validation According to DIN EN ISO 13485
Clinical Evaluation According to MDR 2017/745 & MEDDEV 2.7.1
Software Lifecycle Process According to IEC 62304
References
What Our Customers Say – Success Stories
MST-Instrumente: Work and Time Savings
University Hospital rechts der Isar: Faultless Documentation and Achievement of the IEC 80001-1
Euroimmun: Cost Savings in Usability Engineering
biotrics bioimplants AG: Enrichment of the approval process by BAYOOSOFT Risk Manager
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Continuous Development since 1998 – Version History
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Structured Work According to Lifecycle Phase
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Software Validation – Your Service Options
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Svenja Winkler
Svenja Winkler