Skip to Content

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
Provider Logo

Provider & Contact

Provider Country Portugal
Organisation Website https://medicaldevices.ipn.pt/
Published Email medicaldevices@ipn.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

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