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.
Company Details
- Employees
- 9
- Address
- Lausanne, Ch
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- http://www.lucendra.com
- Keywords
- ISO 13485, 21CFR820 & QMSR, MDR 2017/745 & IVDR 2017/746, ISO 14155 & GCP, 21CFR812, IEC 62366, IEC 62304, ISO 10993 Series, GSPR 10 & 12, MDR Rules 14 & 21, Cleaning (ASTM F3127 & ISO 19227), Ethylene Oxide (ISO 11135 & ISO 10993-7), Radiation (ISO 11137 Series), Steam/Moist Heat (ISO 17665 Series), Shelf-Life (ASTM F1980), Packaging (ISO 11607-1 and-2), ISO 17664-1 & ISO 17665, 21CFR4, ISO 14708 Series, ISO 14971.
- HQ
- Lausanne
Lucendra | Medtech Consulting Questions
Lucendra | Medtech Consulting's website is http://www.lucendra.com
Lucendra | Medtech Consulting's LinkedIn profile is https://ch.linkedin.com/company/lucendra-medtech-consulting
Lucendra | Medtech Consulting has
9 employees.
View email and phone details for 9
employees at Lucendra | Medtech Consulting.
Lucendra | Medtech Consulting's industry is
Medical Equipment Manufacturing
Lucendra | Medtech Consulting's top competitors are
Veranex,
Medical Device Consultancy,
Ricci & Mottaz Sàrl. High Precision Components,
Trialt,
Swiss Medtech,
Med4cast Sa,
Veranex Biocompatibility,
Effectum Medical Ag,
Ide8 | Medical Device Consultancy,
Medidee - Now A Part Of Veranex.
Lucendra | Medtech Consulting's categories are Medical Equipment Manufacturing
