Instituto Pedro Nunes (IPN)

To help companies adopt a "test before you invest" approach, we facilitate access to specific testing infrastructures.

The Requirements Analysis Support Service offers specialized technical and regulatory (MDR) support in the process of identifying, collecting, defining, and documenting medical device requirements.

Product Design and Development: The service has a certified process according to ISO 13485 for the design and development of telemedicine and telerehabilitation solutions, supported by highly specialized multidisciplinary teams in the following areas: Intelligent Systems, Digital Twins, and Collaborative Simulation and Robotics. This set of skills allows for specialized consulting support and monitoring of the complete product development cycle, from conception to technical verification and software and hardware integration.

Support services for the design and development of medical devices in accordance with ISO 13485.

Evaluation of the user interface during the development of medical devices (medical and electromedical software) according to the IEC 62366 standard.

This is a mandatory phase in the design and development of software as a medical device (SaMD) for those seeking to meet regulatory requirements. This is a critical step to ensure that individual components are correctly integrated and that the system functions as expected and as a whole. Integration testing is performed after unit testing and before system testing (verification phase). During integration testing, the individual modules of the product are combined and tested as a group to ensure that all integrated elements function cohesively together. System testing is typically performed after integration testing and before acceptance testing (validation phase). It assesses the overall functionality and performance of a complete and fully integrated solution, ensuring that it operates as expected before reaching the end user.