Lucendra | MedTech Consulting

Lucendra is a Swiss-based full-service MedTech consulting firm, providing agile and pragmatic support to start-ups, SMEs, and strategic companies. We specialise in Quality, Regulatory, Clinical and Scientific services tailored for medical devices, including in vitro diagnostic devices, combination products, (active) implantable medical devices, substance-based devices, medical device software, and wearable devices—spanning from low-risk to high-risk classifications. Our consulting services include: - Implementing and maintaining Quality Management Systems compliant with ISO 13485, 21 CFR 820/QMSR, and MDR/IVDR, as well as conducting and supporting audits/inspections. - Defining regulatory strategies, planning risk management (ISO 14971) and V&V activities, preparing Technical Documentation for submissions and engaging with Notified Bodies (CE Marking) and FDA (Q-submissions, 510(k), De Novo, PMA, BDD, STeP, and 513(g) applications). - Developing clinical strategies, establishing clinical and performance evaluations, planning post-market activities, preparing CTAs and supporting clinical studies following GCP, ISO 14155 and 21 CFR 812. - Developing validation plans for special processes, defining biocompatibility strategies and establishing ADME dossiers for substance-based devices in compliance with MDR GSPR 12. Our experience spans every stage of the medical device lifecycle, including design, development, verification, validation, regulatory approval, manufacturing and market launch. Our expertise extends to various medical specialties, including neurology, cardiovascular, orthopedics, dentistry, ophtalmology, gastroenterology, oncology, (robotic) surgery, rehabilitation, gynecology, anesthesiology and more. Whether you are a start-up navigating regulatory pathways, an SME refining your quality management system, or a strategic launching a complex combination product, we are here to guide you every step of the way.

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