Complear
Complear (Compliance Tech Sociedade Unipessoal LDA) is a specialized consultancy firm based in Guimarães, Portugal, dedicated to providing comprehensive regulatory affairs and quality support services for medical device and in-vitro diagnostic (IVD) manufacturers. Their mission is to help healthcare innovations scale from a technical concept to a market-ready, compliant product by breaking the gap between science and regulatory requirements. Complear offers a suite of services covering the entire regulatory pathway for global markets, including European CE Marking under MDR and IVDR regulations, United States FDA clearance, and Brazilian ANVISA notification. Their expertise extends to implementing Quality Management Systems (QMS) compliant with key international standards like ISO 13485 and 21 CFR 820, as well as specialized support for Software as a Medical Device (SaMD) and AI-based solutions, adhering to standards such as IEC 62304 for software lifecycle processes.
The company is actively involved in high-impact international and national collaborations. Notably, Complear partners with EIT Health to deliver a “Regulatory Pathways to Market Bootcamp” for startups, is a key member of the TB4Health Test Bed consortium in Portugal to accelerate market entry for SMEs, and participates in the Dime International Regulatory Pathways initiative to help harmonize global regulations for digital health products. They are also developing their own proprietary software, the Complear Suite, a cloud-based platform for quality management and technical documentation, in partnership with Delft University of Technology (TU Delft).
In the LASERBLOOD HOP ON project, Complear joins the consortium as a widening partner to provide critical regulatory expertise. Leading Work Package 6 (WP6) – Regulatory Strategy, the team is responsible for establishing a comprehensive regulatory framework for the novel IVD test, ensuring its development aligns with global standards to streamline future market approval. The effort is led by Miguel Amador, Partner and Chief Innovation Officer, and supported by team members such as Emilio Llanos, a QA/RA Consultant specializing in medical and in-vitro diagnostic devices.
Complear’s WP leaders – Miguel Amador and Emilio Llanos
Miguel Amador is the Partner and Chief Innovation Officer at Complear, a position he has held since March 2023. He is responsible for managing the company’s product development, operations, and providing expertise on Medical Device Risk and Engineering. He is currently a Ph.D. Candidate in Bioengineering Systems through the MIT-Portugal Program at Instituto Superior Técnico, with a research 
focus on designing new adaptive regulatory strategies and public policies for health technology innovation. As part of his doctoral studies, he was a Research Visiting PhD Student at the Massachusetts Institute of Technology (MIT) from 2014-2015. He also holds a Master’s degree in Biomedical Engineering from Instituto Superior Técnico. In addition to his role at Complear, Miguel is the Managing Partner at Pi Ventures, an early-stage investor in deep tech companies, and serves as an Expert Evaluator for the European Commission’s EIC Accelerator. Previously, he was the Ecosystem Lead for Portugal at EIT Health InnoStars and Program Manager for Health Tech and NanoTech at Startup Braga.
Emilio Llanos is a Quality and Regulatory (QA/RA) Consultant at Complear, specializing in medical devices, in-vitro diagnostics, and Medical Device Software (MDSW). His mission is to transform science into practical value by helping clients navigate the gap between scientific innovation and regulatory compliance. Emilio holds a Doctor of Philosophy (Ph.D.) in Health Sciences from the Universidad de Castilla-La Mancha (2018-2023), a Master’s degree in Immunology Research from the Universidad Complutense de Madrid (2016-2017), and a Bachelor’s degree in Biology from the Universidad de Extremadura. He is also completing a Master’s 
Degree in Access to the Pharmaceutical Industry + Specialisation in Clinical Trial Management and Monitoring. Prior to focusing on regulatory affairs, Emilio worked as a Predoctoral Biomedical Scientist, leading research projects on Alzheimer’s disease and glioblastoma. He also served as a Research Scientist at Hospital Universitario La Paz, where he investigated the molecular mechanisms of the innate immune system in sepsis, cancer, and cystic fibrosis. He has co-authored several high-impact scientific publications on these topics.
