Company profile
Lucendra | MedTech Consulting
- Industry
- Medical Equipment Manufacturing
- Employees
- 12
- Headquarters
- Lausanne
- Office locations
- 5
Lucendra | MedTech Consulting company summary
Lucendra | MedTech Consulting is a company in the Medical Equipment Manufacturing industry, headquartered in Lausanne. On LinkedIn the company has around 12 employees. The company lists 5 office locations. Its listed specialties include ISO 13485, MDR 2017/745 & IVDR 2017/746, ISO 14155 & GCP, 21CFR812, IEC 62366.
What technology does Lucendra | MedTech Consulting use?
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About 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, Scientific and Digital Health services tailored for medical devices, including in vitro diagnostic devices, combination products, (active) implantable medical devices, substance-based devices, medical device software, AI/ML-enabled 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, QMSR, MDR/IVDR, IA Act, ISO 27001, and ISO 42001, as well as conducting and supporting audits/inspections. - Defining regulatory strategies, planning risk management (ISO 14971), conducting cybersecurity risk management and threat modeling (STRIDE), supporting software life cycle management (IEC 62304/IEC 82304) 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, 21 CFR 812, GDPR and HIPAA. - Developing validation plans for special processes, defining biocompatibility strategies and establishing ADME dossiers for substance-based devices in compliance with MDR GSPR 12. 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 AI/ML product, we are here to guide you every step of the way.
Specialties
Where is Lucendra | MedTech Consulting located?
Lucendra | MedTech Consulting lists 5 office locations.
Compare companies similar to Lucendra | MedTech Consulting
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| Company | Industry | Employees | Founded | Headquarters |
|---|---|---|---|---|
Lucendra | MedTech Consulting lucendra.com | Medical Equipment Manufacturing | 12 | - | Lausanne |
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 BD bd.com | Medical Equipment Manufacturing | 46,224 | - | Franklin Lakes, New Jersey |
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 Zimmer Biomet EMEA zimmerbiomet.com | Medical Equipment Manufacturing | 19,125 | - | Warsaw, Indiana |
 Olympus Corporation olympus-global.com | Medical Equipment Manufacturing | 13,703 | 1919 | Shinjuku-ku, Tokyo |
 Intuitive intuitive.com | Medical Equipment Manufacturing | 13,091 | 1995 | California, 94086 |
 Medline Australia medline.com | Medical Equipment Manufacturing | 18,899 | - | Northfield, IL |
 Edwards Lifesciences edwards.com | Medical Equipment Manufacturing | 14,197 | 1958 | Irvine, CA |
Frequently asked questions about Lucendra | MedTech Consulting
What does Lucendra | MedTech Consulting do?
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, Scientific and Digital Health services tailored for medical devices, including in vitro diagnostic devices, combination products, (active) implantable medical devices, substance-based devices, medical device software, AI/ML-enabled 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, QMSR, MDR/IVDR, IA Act, ISO 27001, and ISO 42001, as well as conducting and supporting audits/inspections. - Defining regulatory strategies, planning risk management (ISO 14971), conducting cybersecurity risk management and threat modeling (STRIDE), supporting software life cycle management (IEC 62304/IEC 82304) 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, 21 CFR 812, GDPR and HIPAA. - Developing validation plans for special processes, defining biocompatibility strategies and establishing ADME dossiers for substance-based devices in compliance with MDR GSPR 12. 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 AI/ML product, we are here to guide you every step of the way.
How many employees does Lucendra | MedTech Consulting have?
Lucendra | MedTech Consulting has around 12 employees on LinkedIn.
Where is Lucendra | MedTech Consulting headquartered?
Lucendra | MedTech Consulting is headquartered in Lausanne.
Where does Lucendra | MedTech Consulting have offices?
Lucendra | MedTech Consulting lists 5 office locations, including Lausanne, CH, CH; Geneva, CH, CH; Lugano, CH, CH; Sion, CH, CH; Zurich, CH, CH.
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