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Integration & System Testing: IEC 62304:2006/Amd 1:2015 and IEC/IEEE 29119-2

Physical Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 52c99046-15af-4183-957e-e9c92ed95979

Service Description

A mandatory phase of design and development of software as a medical devices (SaMD) for those who seek meet the certification requirements is to ensure that the individual components are integrated correctly and the system works as intended work together as intended. IPN’s support in this area includes: • Integration testing, performed after the unit testing to generate evidence that the product's individual modules are combined and tested as a group to ensure that all integrated elements cohesively function together. • System testing, typically conducted after integration testing and before acceptance testing (validation phase), to create evidence that the fully integrated solution operates as expected before reaching its end-user.

Keywords: MDR SaMD Integration testing
Offerings: Research & Development Hardware (Design, Development, Manufacturing, etc.) Testing Conformity & Compliance Hardware (CE, MDR, usability, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Organisation Website https://medicaldevices.ipn.pt/
Published Email medicaldevices@ipn.pt
Billing: per hour
Full Price €85-150 EUR
Reduced Price €0-120 EUR

Operational Details

Certification Support
  • CE Marking
Service Standards
  • IEC 62304:2006/Amd 1:2015
  • IEC/IEEE 29119-2