LAS

Services

Testing and Validation

We ensure that healthcare technologies are verified and validated before they are brought to market, guaranteeing compliance with regulatory requirements and suitability for their intended use.

Our services include:

  • usability studies in line with IEC 62366-1, from study design to execution and reporting
  • clinical investigations in accordance with ISO 14155, including regulatory submissions and study management
  • integration and system testing aligned with IEC 62304 and IEC/IEEE 29119-2
  • feasibility studies for early stage technology validation
  • validation with Key Opinion Leaders (KOLs)
 

All activities are carried out by a specialised multidisciplinary team in close collaboration with clinical partners, including the Local Health Unit (ULS) of Coimbra and a network of international hospitals.

“It was a very positive collaboration, marked by rigor, professionalism, and the quality of the process. For IHCare, this type of initiative is essential to enhance innovation and strengthen confidence in its impact.”

“The KOL validation gave us valuable insights and reinforced the relevance of our solution for health applications. It was a crucial step to refine our strategy and to generate  evidence to support the next development stage.”