Integration & System Testing: IEC 62304:2006/Amd 1:2015 and IEC/IEEE 29119-2
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
Provider & Contact
Provider Organisation
Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
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