We are a full service
medtech
consulting company
The art of combining expertise in engineering, science, regulatory affairs, and business strategy to support all aspects of medical device development – from prototypes to certification and market approval – while maintaining a strong focus on compliance at every stage.
Services
Based in Switzerland, Lucendra is a full-service MedTech consulting company. We provide agile and pragmatic support to start-ups, SMEs, and strategics, offering quality, regulatory, scientific, and clinical services specialized for medical devices.
Quality Management
From implementing and maintaining Quality Management Systems compliant with ISO 13485, 21 CFR 820/QMSR, and MDR/IVDR to conducting and supporting audits/inspections, we deliver comprehensive quality management services.
Regulatory Affairs
From defining regulatory strategies and planning risk management and V&V activities to preparing Technical Documentation for submission and engaging with Notified Bodies and the FDA, we provide robust regulatory support.
Clinical Affairs
From developing clinical strategies and establishing clinical and performance evaluations to planning post-market activities, preparing CTAs and supporting clinical studies, we provide support for all CRO-related activities.
Scientific Affairs
From developing validation plans for special processes, to defining biocompatibility strategies and establishing ADME dossiers for substance-based devices in compliance with MDR GSPR 12, we offer dedicated scientific guidance.
Quality Management
- Implement and maintain Quality Management Systems compliant with ISO 13485, 21 CFR 820/QMSR, and MDR (EU 2017/745) and IVDR (EU 2017/746).
- Coaching/training in preparation for ISO 13485 certification, including support with management reviews, and supplier qualifications.
- Implement and maintain Risk Management processes in compliance with ISO 14971.
- Conduct internal and supplier audits/mock-up inspections.
- Provide hands-on support during audits and inspections, and assist in remediating non-conformities.
- Structure Technical Documentation per regulatory requirements, including Design History File (21 CFR 820.30j).
- Establish and maintain Post-Market Surveillance processes, including complaint handling, adverse event reporting and FSCAs.
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Facilitate data-driven continuous QMS improvements through CAPA process.
Regulatory Affairs
- Develop regulatory pathways for novel medical devices.
- Prepare Technical Documentation and submissions for CE marking under MDR and IVDR.
- Support with D&D activities, in defining design inputs based on applicable standards, and integrating Risk Management in accordance with ISO 14971.
- Design and planning of V&V, including product specific verification activities, and usability validation per IEC 62366.
- Support FDA interactions, including Q-submissions, 510(k), De Novo, PMA, BDD, STeP, and 513(g) applications.
- Facilitate global market access and manage regulatory submissions across other regions (e.g. Canada, Middle East, Australia).
- Interact with Regulatory Authorities, including support in addressing deficiency reports.
- Deliver Regulatory Affairs training tailored to your needs.
Clinical Affairs
- Define clinical strategies and Clinical Development Plans (CDPs) for EU and US market access, aligning regulatory and clinical needs.
- Write Clinical Evaluations compliant with MDR and MDCG guidances.
- Design clinical investigations following GCP and ISO 14155.
- Prepare Clinical Trial Applications (CTA) and oversight of studies in the EU (MDR, GCP).
- Prepare Investigational Device Exemption (IDE) submissions for clinical studies in the US in compliance with 21 CFR 812.
- Manage interactions with Regulatory Authorities, Ethics Committees and IRBs from submission and initiation to monitoring and close-out.
- Establish PMCF Plans and Reports to fulfill Post-Market Surveillance obligations.
- Provide Clinical Affairs training tailored to your needs.
Scientific Affairs
- Conduct Biological Evaluations per MDR and ISO 10993-1.
- Perform Toxicological Risk Assessments following ISO 10993-17.
- Assess substances/materials for CMR compliance (GSPR 10).
- Develop ADME dossiers for substance-based devices (GSPR 12, MDR Rules 14/21).
- Provide specialist assessments and test designs for biodegradable devices.
- Plan validations for special processes, including cleaning (ASTM F3127, ISO 19227), sterilization methods, as ethylene oxide (ISO 11135, ISO 10993-7), radiation (ISO 11137 series), steam/moist heat (ISO 17665 series), shelf-life (ASTM F1980), and packaging (ISO 11607-1 and-2).
- Validate reusable medical device processing (ISO 17664-1, ISO 17665).
- Deliver training on Biological Evaluation, ADME, process validation, and sterility assurance.
Expertise
We offer our clients expert support across a wide range of medical devices, including In Vitro Diagnostic devices and Combination Products, spanning from low-risk to high-risk classifications.
Our expertise extends to various medical specialties, including neurology, cardiovascular, orthopedics, dentistry, ophtalmology, gastroenterology, oncology, (robotic) surgery, rehabilitation, gynecology, anesthesiology and more.
Substance-based Medical Devices
Defend classification and define requirements applicable to substance-based devices.
Conduct literature review to evaluate modes of action of individual substances present within the device.
Prepare dossier to outline ADME evidence in compliance with GSPR 12.1 or GSPR 12.2. Support with design of any additional testing required.
Combination Products
Classify Combination Products based on their primary mode of action (PMOA).
Prepare Technical Documentation for device-part to obtain Notified Body Opinion (MDR, Article 117).
Implement QMS combining medical device and drug-related cGMP requirements for developing combination products compliant with 21 CFR part 4 and applicable ICH guidelines.
(Active) Implantable Medical Devices
Define clinical, non-clinical testing, and preclinical study designs, for implantable and long-term degradable devices.
Optimize V&V strategy for Active Implantable Medical Devices (AIMDs) and brain electrodes (ISO 14708-x series), based on their development phase (e.g. preparation for preclinical studies, FIH trials or pivotal clinical studies).
In Vitro Diagnostic Medical Devices
Prepare transition from IVDD to IVDR, including product classification, gap analysis of QMS/Technical Documentation as well as associated action plan to implement remediations.
Review Risk Management File and V&V reports, including evidence supporting the Scientific Validity, Analytical Performance and Clinical Performance.
Medical Device Software
Conduct Clinical Evaluation of MDSW demonstrating its Valid Clinical Association, as well as Technical Performance and Clinical Performance.
For AI-enabled MDSW, review Technical Documentation to ensure it adequately describes the algorithm and its development (e.g. how training, validation and test datasets were defined) while minimizing risks such as bias.
Active and Wearable Medical Devices
Prepare Technical Documentation, ensuring that key standards such as IEC 60601-1 and IEC 60601-1-2 have been integrated into Design Inputs and V&V strategy.
Review software documentation for compliance with IEC 62304 and for completeness against state-of-the-art (e.g. cybersecurity considerations for connected wearable medical devices).
Shedding light on regulatory compliance for Medical Devices
Committed to innovation and excellence, we combine deep technical knowledge, scientific rigor, and strategic business insight to support our clients. 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.
cumulated years of experience
regulatory submissions
audit days
clinical strategies
biocomp strategies
Cups Of Coffee
About us
We are a multidisciplinary team of engineers, scientists, and business professionals with extensive expertise in bringing medical devices to market. Our experience spans every stage of the medical device lifecycle, including design, development, verification, validation, regulatory approval, manufacturing and market launch.
At Lucendra, we take pride in our pragmatic and agile approach, helping our clients achieve compliance and success while improving patient outcomes.
Dominique Vaney
Senior Partner
Jurjen Zoethout
Senior Partner
Jurjen has over 25 years of experience in the MedTech industry, specializing in research, product, and business development with a strong focus on regulatory, quality and clinical aspects. He excels in developing regulatory strategies for the EU and US markets, ensuring compliance, successful product launches, and effective interaction with Regulatory Authorities. Jurjen has coached and supported numerous startups, co-founded three innovation-driven companies, and his expertise has been instrumental in the growth and success of various organizations in the MedTech sector.
Richard Curno
Senior Partner
Eloïse Lovejoy
Principal Consultant
With an MSc in Industrial Systems Engineering, Eloïse brings over 10 years of MedTech industry experience specializing in Quality and Regulatory Affairs. She has expertise in all aspects of Quality Management Systems, from implementation to auditing and certification, and in navigating complex regulatory landscapes. Eloïse has successfully led projects from concept to market clearance, ensuring global compliance. Known for her pragmatic approach, she addresses challenging requirements with innovative solutions while delivering high-quality outcomes aligned with industry standards and customer needs.
Adrien Marchand
Principal Consultant
Adrien brings 10 years of experience in scientific method development and over 5 years in MedTech consultancy as a Biocompatibility Specialist. He supports clients in identifying chemical and biological risks, defining pragmatic testing strategies, and evaluating results within toxicological assessments. Adrien has expertise in cleaning and sterilization validation for novel and reusable devices and works closely with Regulatory Authorities to address compliance and facilitate successful submissions. His scientific expertise is also key to defining regulatory strategies for substance-based products.
Rima Padovani
Principal Consultant
Rima is a biomedical engineer with over a decade of expertise working with medical devices, and holds the RAC (Devices) certification. With a strong background in R&D and passion for innovation, she specializes in delivering pragmatic, evidence-based support across D&D, V&V, risk management and clinical evaluation, covering high-risk and novel devices. Rima has successfully guided clients through all stages of the device lifecycle, from defining regulatory pathways and developing clinical strategies to engaging with regulatory authorities to ensure compliance.
Linda Ahnen
Principal Consultant
Linda is a physicist with a PhD in Biomedical Engineering and RAC (Devices) certification. She has over five years of experience in Regulatory and Clinical Affairs, specializing in clinical strategies, regulatory pathways, and technical documentation for CE and FDA submissions. With a strong foundation in clinical investigations, risk management and usability engineering, Linda supports innovative MedTech projects from early development through to compliance. Known for her pragmatic approach and scientific rigor, she delivers effective, compliant solutions to complex challenges.
Anna Amovilli
Senior Consultant
Anna is a biomedical engineer with over three years of consulting experience in Clinical and Regulatory Affairs within the MedTech industry. She holds the RCC-MDR certification from RAPS and specializes in clinical investigations, from identifying pragmatic clinical strategies to study design, approval, execution, monitoring and reporting. Anna has also expertise in preparing technical documentation for clinical trials and market approval submissions. She ensures compliance with EU and US regulatory requirements and supports the deployment and maintenance of Quality Management Systems.
Get in touch
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