Instituto Pedro Nunes (IPN)

Consulting services in areas related to Quality.

Specialized services for implementing normative or regulatory requirements, namely the implementation of management systems, monitoring, including, where applicable, audit and training components.

Training management

Development of content tailored to each individual case, always with work solutions (consulting/training) that value practice, creativity, and innovation. IPN is a certified training entity (certificate no. 2376/2016) by the Directorate-General for Employment and Labour Relations (DGERT).

Gestão de formação

Development of content tailored to each individual case, always with work solutions (consulting/training) that value practice, creativity, and innovation. IPN is a certified training entity (certificate no. 2376/2016) by the Directorate-General for Employment and Labour Relations (DGERT).

Support in the CE marking process for medical devices (CE Mark Regulation EU 2017/745)

Supports manufacturers, distributors and importers of medical devices in the CE marking process, in accordance with Article 20 of Regulation (EU) 2017/745 (MDR), including the implementation and review of the Quality Management System according to ISO 13485, the preparation or updating of Technical Documentation (Annexes II and III), the clinical and biological risk assessment, the UDI/EUDAMED registration, the submission to Notified Bodies and, where applicable, support in identifying an authorized representative.

Issuance of Biological Assessment Report (BER)

Preparation of the biological assessment report in accordance with ISO 10993. Biological assessment is an essential process in the development of medical devices, designed to evaluate their safety and biocompatibility in interaction with biological systems, ensuring that the materials used do not cause adverse biological responses, in accordance with ISO 10993, through the preparation of a Biological Assessment Plan (BEP) and a Biological Assessment Report (BER) that demonstrate the safety and regulatory compliance of the device.

Post-Market Surveillance (MDR) report.

Preparation and review of the Post-Marketing Surveillance Plan (PMS), as well as the preparation of PMSR or PSUR reports, ensuring continuous monitoring of the safety, quality and performance of medical devices throughout their entire life cycle, in accordance with regulatory requirements.

Specialized Training in AI [MDR]

The IPN's MDR department includes qualified trainers who provide specialized training in the area of medical device regulation and in vitro diagnostics, with our greatest expertise in Regulation (EU) 2017/745, Regulation (EU) 2017/746, Risk Management (according to ISO 14971:2019), Quality Management Systems (according to ISO 13485), and Clinical and Performance Evaluation. Among our offerings is a specialized training program focused on AI applications in medical devices.

Summative usability testing (IEC 62366-1:2015) (MDR products)

The implementation of Summative Usability Tests, in accordance with IEC 62366-1:2015, evaluates the medical device interface with end users, identifying usability errors and opportunities for improvement, through study design, support to the clinical team, participant recruitment, monitoring, data collection and report preparation according to good clinical practices.

Análise e apoio à implementação do Sistema de Gestão da Qualidade (de acordo com ISO 13485:2016, MDR e outras normas relevantes)

IPN supports medical device manufacturers in implementing Quality Management Systems according to ISO 13485, aligned with Article 10 of the MDR, preparing organizations for certification audits.

Internal Audit (ISO 13485:2016, MDR)

The auditors from IPN's regulatory support unit conduct remote and fully independent audits of quality systems, both for companies with ISO 13485 certification already implemented and for companies that wish to prepare for their first ISO 13485 certification audit.

Apoio no processo de marcação CE de dispositivos médicos (CE Mark Regulation EU 2017/745 )

Supports manufacturers, distributors and importers of medical devices in the CE marking process, in accordance with Article 20 of Regulation (EU) 2017/745 (MDR), including the implementation and review of the Quality Management System according to ISO 13485, the preparation or updating of Technical Documentation (Annexes II and III), the clinical and biological risk assessment, the UDI/EUDAMED registration, the submission to Notified Bodies and, where applicable, support in identifying an authorized representative.

Emissão de Relatório de Avaliação Biológica (BER)

Preparation of the biological assessment report in accordance with ISO 10993. Biological assessment is an essential process in the development of medical devices, designed to evaluate their safety and biocompatibility in interaction with biological systems, ensuring that the materials used do not cause adverse biological responses, in accordance with ISO 10993, through the preparation of a Biological Assessment Plan (BEP) and a Biological Assessment Report (BER) that demonstrate the safety and regulatory compliance of the device.

Emissão de relatório de Vigilância Pós-Mercado (MDR)

Preparation and review of the Post-Marketing Surveillance Plan (PMS), as well as the preparation of PMSR or PSUR reports, ensuring continuous monitoring of the safety, quality and performance of medical devices throughout their entire life cycle, in accordance with regulatory requirements.

Implementation of a Quality Management System (in accordance with ISO 13485:2016, MDR, IVDR and other relevant standards)

The RDM and RDIV establish, in article 10, paragraph 9 and article 10, paragraph 8 respectively, the requirements for the manufacturer's QMS (according to ISO 13485 and/or ISO 9001). Although not explicitly stated, ISO 13485 is the most suitable quality management system standard for medical device companies. To effectively implement ISO 13485, manufacturers (and other economic operators) need to use documentation to control their internal processes. IPN's regulatory support unit helps manufacturers identify/create the necessary processes and develop/update the associated documentation to demonstrate compliance with the standard. The documentation is not restrictive and is tailored to each organization. Thus, to meet the requirements and also the specific needs of operators, our consultants work closely with representatives from each section or department. After developing an implementation plan, our team helps manufacturers build their system with the necessary quality manual and documented procedures and records, in order to prepare them for a certification audit.

Formação Especializada em IA [MDR]

The IPN's MDR department includes qualified trainers who provide specialized training in the area of medical device regulation and in vitro diagnostics, with our greatest expertise in Regulation (EU) 2017/745, Regulation (EU) 2017/746, Risk Management (according to ISO 14971:2019), Quality Management Systems (according to ISO 13485), and Clinical and Performance Evaluation. Among our offerings is a specialized training program focused on AI applications in medical devices.

Teste de usabilidade Sumativa (IEC 62366-1:2015) (produtos MDR)

The implementation of Summative Usability Tests, in accordance with IEC 62366-1:2015, evaluates the medical device interface with end users, identifying usability errors and opportunities for improvement, through study design, support to the clinical team, participant recruitment, monitoring, data collection and report preparation according to good clinical practices.

Electrical and morphological characterization (Micro-CT, AFM, Profilometry, MO)

Dynamic and static mechanical characterization (universal tensile, compression and bending tests), morphological (microCT, AFM) and chemical (chromatography, spectroscopy, etc.) characterization for evaluating the performance of solutions.

Mechanical characterization of materials/prototypes (Deformation, bending, fatigue tests)

Dynamic and static mechanical characterization (universal tensile, compression and bending tests), morphological (microCT, AFM) and chemical (chromatography, spectroscopy, etc.) characterization for evaluating the performance of solutions.

Apoio a estudos de investigação clínica ISO 14155:2020

Preparation of the Clinical Evaluation Report in accordance with the MDR. Compliance with the MDR requires a robust Clinical Evaluation that demonstrates the safety, performance, and clinical benefits of a medical device through a systematic assessment of clinical data related to the device.

Analysis and support for the implementation of the Quality Management System (in accordance with ISO 13485:2016, MDR and other relevant standards)

IPN supports medical device manufacturers in implementing Quality Management Systems according to ISO 13485, aligned with Article 10 of the MDR, preparing organizations for certification audits.

Identifying and matching partners (negotiation)

Project alignment with national and European incentive schemes. In-person or online meetings.

Apoio na procura de oportunidades de financiamento nacional

Identifying funding opportunities, particularly Venture Capital and Business Angels. Acting as an intermediary between the company and the investor.

Support services for financial execution and monitoring of applications for national funding.

Preparation of the financial execution dossier for the application; verification of documentation and submission on the digital platform. Full monitoring of the project's financial execution.

Mapping and identifying funding opportunities.

Identification and strategic advice on funding opportunities (National/European), through analysis of the organization's activities and continuous monitoring of relevant European, national and regional programs. Ensures regular updates and personalized recommendations to maximize access to funding and align projects with the priorities of available support programs.

Disseminação de oportunidades de financiamento nacional

Dissemination of funding opportunities nationwide through IPN's communication channels.

Assistance in preparing and submitting applications for national and international funding.

This service provides support in preparing and submitting applications for national and international funding.

Serviços de apoio à execução financeira e acompanhamento de candidaturas a financiamento nacional

Preparation of the financial execution dossier for the application; verification of documentation and submission on the digital platform. Full monitoring of the project's financial execution.

Support in finding national and international funding opportunities.

Support in finding national and international funding opportunities.

Serviços de preparação e submissão de candidaturas a financiamento nacional

Preparation of economic and financial plans and support the company in the preparation, review, validation and insertion of texts and other content related to applications for incentive schemes.

Full support in the preparation of European proposals.

Support in finding partners to integrate into a research and development consortium for a service/product (direct interaction with scientific laboratories).

Specialized training in Innovation and Entrepreneurship

Assistance in preparing and submitting applications for various investment incentive programs, research and development grants, funds, employment opportunities, and others.

Access to training courses in technological and management-related topics.

Companies benefit from continuous training opportunities that cover a wide range of technological advancements and management practices, equipping employees with relevant skills and knowledge.

Access to regular training courses in technological and management-related topics.

Service geared towards multicenter research: complete mapping of ObsCare® variables, analysis of the pregnancy journey, scientific dictionaries, data harmonization, and creation of dashboards or scientific modules on ObsCare®. Ensures methodological robustness and compatibility with real NHS data.

Support in business plan development

Assistance in developing a comprehensive business plan, ensuring it aligns with company objectives and market demands.

Acompanhamento na elaboração do Plano de Negócios da empresa

Identify products that are based on a relevant technology and the respective markets for those products.

Support in attracting investment and securing funding

To diagnose the current level of digital maturity, mapping capabilities, processes, and technologies, and to prioritize transformation initiatives in order to promote operational efficiency.

Support in applications for Incentive Schemes for Investment, R&D, Innovation, Employment, among others.

Assistance in preparing and submitting applications for various investment incentive programs, research and development grants, funds, employment opportunities, and others.

Candidaturas a Sistemas de Incentivos ao Investimento, I&D, Inovação, emprego, entre outros

This service consists of an integrated solution of specialized consulting and technical assistance in supporting applications and in the management and execution of funded R&D projects in various fields.

Integration with various national and international research centers, other sources of knowledge, funding sources, etc.

This service ensures that entrepreneurs have access to a network of research institutions, knowledge centers, funding opportunities, and international collaborations.

Integração com diversos centros de investigação nacionais e internacionais, outras fontes de conhecimento, fontes de financiamento, etc

This service provides support and advice during the initial stages of creating and launching a business, helping entrepreneurs navigate the technical aspects of business setup.

Technical guidance during the company formation and start-up phase.

This service provides support and advice during the initial stages of creating and launching a business, helping entrepreneurs navigate the technical aspects of business setup.

Orientação técnica na fase de constituição e arranque da empresa

To demonstrate, disseminate, and promote the results of technological development within the business community.

Accounting and tax planning services

Professional accounting and finance experts offer comprehensive accounting services and strategic tax planning.

Serviços de contabilidade e planeamento fiscal

The Specialized Training in Innovation and Entrepreneurship - EIT Health PHD School is aimed at future entrepreneurs who have a business idea based on technological or academic R&D results. Participants take part in a learning path that guides them, module by module, through all the main steps to accelerate the creation of a startup, based on IPN's unique innovation and entrepreneurship methodology. The course includes an initial needs assessment, which participants can carry out as a self-assessment or with the support of a project manager or tutor.

Intellectual Property and legal advice (e.g., technology transfer agreements, patent registration, trademarks)

Professional accounting and finance experts offer comprehensive accounting services and strategic tax planning.

Support services for intellectual property

Drafting patent applications or other industrial property rights applications.

Serviços de apoio à proteção de propriedade inteletual

Companies benefit from continuous training opportunities that cover a wide range of technological advancements and management practices, equipping employees with relevant skills and knowledge.

Custom development

Custom software development

Definição e desenvolvimento de modelos de negócio

Execution of business plans, definition of the business model, and preparation of economic and financial projections.

Digitization and Sensorization of Industrial Processes

Product life cycle assessment (report)

Digitization of industrial processes

Access to the IPN international network

Access to testing infrastructure

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

Requirements Analysis

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

Technical consulting for the design and development of medical devices in accordance with ISO 13485.

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.

System design and architecture

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

Design e arquitetura de sistema

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

Formative Usability Studies (IEC 62366)

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

Estudos de Usabilidade Formativa (IEC 62366)

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

Integration tests and system tests according to IEC 62304:2006/Amd 1:2015 and IEC/IEEE 29119-2

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.

Testes de integração e testes de sistema conforme IEC 62304:2006/Amd 1:2015 e IEC/IEEE 29119-2

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.