Services

Testing and Validation

In the scope of the medical devices certification process, Instituto Pedro Nunes provides services for the testing and validation of health technologies, considering the regulatory framework in force. These services lie in supporting the conduction of pre-clinical tests, as well as the design, implementation, monitoring and data management of clinical investigation studies of medical devices. These activities are performed in close cooperation with our partner clinical units – Unidade Local de Saúde (ULS), among other TEF-Health hospitals.

Electromagnetic compatibility (EMC) Pre-Compliance Testing  (EN 55032:2015/A11:2020)

How to ensure the device passes the EMC Radiated Emission test (EN 55032:2015/A11:2020)? A pre-compliance setup involving your team can be used to quickly isolate the “dominant noise source” and enable the design team to focus on a single component of the device. By fast comparative testing of that possible culprit with different options or small design adjustments, you can produce the necessary reassurance to quickly send the device back to the final EMC Radiated Emission test to put the device on the market.

Usability Testing (IEC 62366-1:2015)

Formative Usability Testing Implementation
Formative usability testing is not intended to evaluate the safety and performance of a device comprehensively. This service focus on an Iterative process where usability tests are carried out early and repeatedly during the development of the device.

The goal of this service is to identify and correct any usability problems before the device is finalized, this means:

        • Early identification of problems;
        • Iteration and feedback;
        • User involvement;
        • Focus on improvement.

Summative Usability Testing Implementation
User interface evaluation conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors “Medical devices – Part 1: Application of usability engineering to medical devices”: The purpose of the usability testing is to identify approaches to make a product more user friendly for its intended users. The usability testing focuses on the user experience with the device, including the device’s graphical user interface (GUI), providing valuable insights into how users interact with the product and what improvements can be made to enhance their experience. The results of usability testing allow product developers, managers, and marketers to refine the product and ensure that it meets the needs and expectations of its users. By leveraging the insights obtained from usability testing, companies can develop a final product that is not only functional but also intuitive and enjoyable to use, leading to increased user satisfaction and loyalty. The service includes the design of the study, support on the definition of the clinical team, supporting clinical researchers in managing patient recruitment, monitoring the research, and data collection according to good clinical practices and reports.

Clinical Investigation

Support in Clinical Investigation Documentation
Considering the regulatory requirements for the clinical investigation studies submission to ethics committees and competent authorities (e.g. Annex XV of the MDR for clinical investigation studies in the European Union), our experts are able to support companies in the preparation of documents through an integrated approach comprising:

  • Structuring Clinical Investigation Plans (CIPs): Clear and detailed guidance is offered for creating CIPs that meet the requirements of Annex XV of MDR, ensuring all essential elements.
  • Preparing Investigator’s Brochure and Informed Consent Documents: Support is provided in developing Investigator’s Brochures and informed consent forms, ensuring the protection of the rights, safety, and well-being of study participants while meeting MDR requirements.
  • Developing Clinical Investigation Reports (CIRs) and Supporting Documentation: The team ensures that final CIRs and supplementary materials are meticulously prepared, accurately reflecting study results and aligning with regulatory expectations.
  • Assistance with completing specific forms for local ethics committees and Competent Authorities in different countries is also provided.

By offering expertise and practical support in these areas, this unit facilitates the preparation and submission of essential documentation to ethics committees and competent authorities, ensuring that clinical investigations meet the rigorous standards set forth by the MDR framework.

Clinical Investigation Management
In cooperation with each hospital, Instituto Pedro Nunes Clinical Research Coordinators support clinical researchers in managing patient recruitment, monitoring the research, and data collection according to ISO 14155:2020 – Clinical investigation of medical devices for human subjects — Good clinical practice, ensuring the quality of the clinical evidence generated.

Along the innovative product/solution development pathway relevant go-no-go decisions should be taken into account. To ensure the suitability of the design and/or the product/solution market receptiveness, critical milestones should be checked in early phases to anticipate the health technology optimal launch.

By granting the product/solution a KOL validation, by clinical experts through a systematic assessment approach, in a timely manner, will reduce the risk of failing the next steps of the way.

IPN, in collaboration with Coimbra University Hospital – Unidade de Saúde Local de Coimbra (ULS-C) and the synergies settled through the TEF-Health partnership, counts on the expertise of high-tier health clinical professionals to provide new technologies assessment in a 3-step way,

          1. Preliminary evaluation: the KOL self-assesses the product/solution provided information, to evaluate its medical purpose assumptions? If it answers an unmet medical need? competitor(s) in the market? Strengths/weaknesses of the technology? etc.
          2. Short meeting: a 1:1 one-hour meeting, where the KOL is briefed with a 10-15 mins. demonstration of the product/solution, followed by a discussion of the concerning queries.
          3. Expert assessment report: a report is issued addressing insight on the raised hot topics, including suitability strengths, weaknesses, opportunities and threats analysis (SWOT) analysis and useful recommendations/ suggestions to be considered.

* Tier I – High: health care professional with international recognition (publications/communications) and >10 years of experience in the respective clinical (sub)speciality; Tier II – Medium: health care professional with national recognition (publications/communications) and 5-10 years of experience in the respective clinical (sub)speciality; Tier III – Low: local recognition health care professional with < 5 years’ experience in the respective clinical (sub)speciality.