Laboratory for Automatics and Systems

The Automatics and Systems Lab (LAS) develops R&D and technology transfer activities in partnership with companies, in the field of Embedded Systems, Collaborative Robotics, Internet of Bodies, Validation, Evaluation and Certification of medical devices.

What we do

With a multidisciplinary team and integrated expertise, our work focuses on:

  • Product design and development
  • Testing and validation of medical devices and digital health solutions
  • Regulatory support for medical devices and quality management


With over 15 years of experience in Digital Health, we operate a process certified under ISO 13485 for the design and development of telemedicine and telerehabilitation solutions, in the following technological domains:

  • Intelligent Systems
  • Digital Twins and Simulation
  • Collaborative Robotics


We work closely with the University of Coimbra and the Institute of Systems and Robotics, bringing advanced research into real-world healthcare applications.

Fields of activity

We Contribute to accelerate the transition from applied research to innovation, strengthening companies' competitiveness through joint development of AI & Robotics technologies for Health .

Working under ISO 13485–certified processes, our multidisciplinary teams provide end-to-end support across the product lifecycle. We combine expertise in intelligent systems, digital twins and simulation, and collaborative robotics.

We work with both software and hardware technologies, helping organisations turn ideas into reliable and scalable solutions.

We test and validate healthcare technologies before market deployment. 

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 
  • early-stage feasibility studies   
  • 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. 

We help organisations navigate regulatory requirements and prepare medical devices for market approval. 

Our services include: 

  • support in obtaining CE mark under the Medical Device Regulation (MDR) and the AI Act  
  • implementation/adaptation of Quality Management Systems aligned with ISO 13485, MDR, AI Act and 21 CFR 820  
  • elaboration/revision of Technical Documentation (including BEP/BER, CEP/CER, Risk Management, PMSR and PSUR)  
  • assist with US market access, including preparation/revision of pre-submissions, 510(k), De Novo, and PMA  
  • regulatory consulting  
  • internal audits  
  • specialized training 


We help organisations manage regulatory complexity, ensuring their technologies are safe, compliant and ready for market.
 

Contacts

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