Class Definition of your Medical Device.
Establish a Quality Management System.
Risk Management Plan for CE Marking and/or FDA clearance.
Clinical Evaluation. How to design, when to apply and more.
Build your Strategic Roadmap for evidence demonstration and Registration Dossier filing.
Access to Market to identify and estimate the target populations, as well as the price potential.
CE mark vs FDA requirements, setting one foot on each side of the Atlantic NGHD’s DNA.
Digital Option
Digital Medical Device conception (62304 implementation)
Establishing a software under the Medical Device status is a challenge, different standards apply, development under the “agile” form is possible under certain conditions.
IVD (In Vitro Diagnostic) Option
Implementation IVDR 2017/746/EU
The development of an IVD follows a specific regulation which evolves with the new adjustment.
Dedicated team
Senior Director, Medical Devices & Digital Life Sciences
As a Senior Director at VCLS, Christophe is responsible for leading the Medical Device and Digital Life Science Group. The Group specializes in providing advice to manufacturers of digital health technologies and ground-breaking medical devices on the design and implementation of international regulatory strategies, from an early stage of development through to market access.
Christophe has specific expertise in anticipating the regulatory and practical challenges frequently associated with innovative systems such as breakthrough digital technologies. This expertise encompasses e-health/m-health products, drug-device combinations, and in vitro diagnostics. He is also responsible for the review and submission of regulatory applications in Europe and the US, including dossiers to support CE marking, 510(k)/DeNovo/PMA and Pre-market approval, and in leading interactions with multiple regulatory bodies (e.g. Notified Bodies and National Health Competent Authorities).
Christophe brings to the role more than 20 years of Medtech experience, having worked in both SMEs and large international firms, such as Boston Scientific. During this time, he gained significant experience in the active medical device industry, in particular in next-generation implantable stimulators for neurological diseases (pelvic nerve stimulation for incontinence and spinal nerve stimulation for chronic headache). He was also responsible for the management of international proof of concept clinical trials across Europe for a wide range of innovative therapeutic indications and advanced neuroprosthetic devices in the areas of pain management and pelvic health.
Christophe began his career in 1998 at Advanced Bionics in its auditory division, working as a clinical specialist. Whilst there, he acquired an in-depth knowledge of auditory nerve stimulation to treat profound deafness. In particular, he was responsible for assisting operating theatre staff during surgical procedures and providing expertise on related products to practitioners to support post-operative programming visits with patients.
Christophe earned his Master of Science in biomedical engineering from the University of Technology of Compiègne (UTC), France, and he holds a Bachelors degree in biomedical science from the University of Toulouse, France.
Senior Regulatory Scientist, Clinical Trials and Regulatory
As Clinical Project Manager (CPM) in the Clinical Trial Submissions and Operations team at VCLS, Anne-Charlotte is responsible for coordinating and supervising the conduction of clinical studies (Medical Device & In vitro Diagnostic Medical Device). She is also involved in the management of the settings and the monitoring of clinical projects in compliance with ICH guidelines and local/international regulations. Anne-Charlotte provides advice on In Vitro Diagnostic Medical Device Development. Anne-Charlotte brings more than 15 years’ experience in the Pharmaceutical industry, involved in the development of Diagnostic tests in the field of Alzheimer’s disease & various cancers (breast, thyroid). She was responsible for the management of clinical performance studies and the constitution and maintenance of regulatory product files. Before joining VCLS, Anne-Charlotte worked at Diaxonhit, a Diagnostic Company, as Project Leader in IVD Research & Development Department for 12 years. Anne-Charlotte has also significant experience in Neuroscience Research & Development. Doctorate in Micro-organisms Genetics, Anne-Charlotte is a graduate of the National Agronomic Institute of Paris-Grigon_Paris XI. Anne-Charlotte is based in the Paris office.
Senior Director, Market Access
As Senior Director Market Access, Jerome is responsible for market access strategy for any healthcare product or technology. This includes evidence generation review, real world evidence planning and strategy for global value dossier.
Experienced Director (33 years) with a demonstrated history of working in the pharmaceuticals industry. Strong professional skilled in Market Access, Health Economics, Clinical Research and Medical Devices.
From his experience in several roles in clinical development in big pharma, Jerome acquired the “data” culture. Thereafter, he completed his skills and moved to positions in health economics and market access at global and at affiliates levels in different pharma companies (Sanofi, Ipsen).
In-between, he spent some time in Montpellier university hospital in an innovation department dedicated to the health economics assessment of medical devices, he was member of hospital committee (COMEDIMs) in charge of evaluation of health innovations and launched a medical platform to support local MedTech companies.
More recently, Jerome initiated real world evidence project for a genomic test in the field of the personalized medicines and provided medical/scientific support to a digital health start-up.
At this moment, his main interest is about real-world evidence (RWE) development and how RWE can bring values to any healthcare product/technology in the frame of its clinical development and market access.
Jerome is PharmD graduated from the University of Montpellier with additional degrees in epidemiology/biostatistics from the University of Paris and in health economics from the University of Lyon.
Jerome is co-author of more than 20 peer-reviewed publications.
Jerome is in Boulogne and remotely in Montpellier.
Director, Medical Devices and Combination Products
Michael Husband received his Bachelor of Engineering in Biomedical and Chemical Engineering from Vanderbilt University and his Masters of Science in Biomedical Engineering from Johns Hopkins University.
Michael started his career in the industry in medical device research and development for novel ways to measure respiratory and anesthetic gasses. He collaborated on several patents involving calculations of metabolic rate and cardiac output via respiratory gas flow measurement. He also gained clinical trial experience as a clinical engineer managing clinical trials for prostate and breast cancer tumor ablation treatment.
He began his government service with the Food and Drug Administration (FDA) as a senior medical device reviewer and Branch Chief for anesthesiology and respiratory devices specializing in the review of respiratory drug delivery systems, closed-loop ventilation, and anesthesia systems, and decision assist software for multi-parameter vital signs monitors. He then moved to the Biomedical Research and Development Authority (BARDA) where he worked as a Project Officer leading advanced development efforts for ventilators, respiratory personal protection equipment, influenza diagnostics, and vaccine delivery devices in support of pandemic preparedness.
Michael transitioned to the US Army Medical Research and Materiel Command (USMRMC) and continued to lead advanced development efforts for medical products in the area of combat casualty care with a focus on traumatic brain injury and psychological health diagnostics and treatments. He then took over as the Director of the Office of Regulated Activities where he set up an independent office to develop regulatory strategy and support for all medical products developed and funded by the Army and the Defense Health Agency (DHA). He was a key leader in working with the FDA on navigating Public Law 115-92 and the July 2018 Emergency Use Authorization for freeze-dried plasma.
Director, Medical Device
As a Director of Medical Devices, Andromachi is responsible for defining and implementing regulatory strategies for the development and registration of innovative medical device/ HealthTech products as well as mentoring of early-stage start-ups. Through her role, she is determined to drive awareness of the changing medical device regulatory landscape using a variety of methods and channels. Her responsibilities also include activities supporting the successful certification against ISO 13485, MDSAP and MDR as well as assisting manufacturers to navigate the relevant regulatory requirements whilst ensuring they can remain agile.
Andromachi brings to the role more than 9 years of experience in the medical devices industry having worked with active device manufacturers of different regulatory maturity and product risk profile. During that time, she developed expertise in QMS development, implementation, certification and remediation in line with ISO 13485, 21 CFR 820, MDR and all MDSAP markets. She has also been instrumental in the transition of Technical Files from MDD to MDR, along with SaMD product up-classification. Having had several interactions with EU, UK and Canadian regulators as well as Notified Bodies on classification, certification and reporting matters, she is equipped with the experience required to anticipate the challenges that may arise and aims to ensure that strategies and roadmaps developed for medical devices take these into account. Finally, having worked extensively with software manufacturers, she is experienced with software development practices and how these could be adapted to meet regulatory requirements.
Andromachi began her career as a Research Assistant for a medical device laboratory, focusing on antennas for implantable and on/near-body wireless devices, where she experienced and better understood the challenges of designing innovative products as well as the considerations required to ensure successful transfer to manufacturing and subsequently to market. This understanding was further supported by subsequent roles that involved working with contract manufacturers and then bringing manufacturing in-house, whilst ensuring a smooth transition and successful site verification audit by the Notified Body.
Andromachi earned her Master of Science in Biomedical Engineering from Imperial College London, UK, and holds a Master of Engineering in Electrical and Computer Engineering from the National Technical University of Athens, Greece. Andromachi is based in London, UK.
Director, Drugs, Medical Devices & Microbiome-based products
As Director, Clara supports companies in the development and implementation of global regulatory strategies for the development, evaluation and marketing of medical devices, drugs (incl. biological medicinal products), as well as combination products. She specifically support developers of microbiome-based health products. She supports realization of projects as project lead and advisor.
Clara’s role includes strategic positioning of complex and borderline health products, building adapted development plans, preparation and participation to agencies consultations, and development of regulatory submissions to support marketing authorizations for therapeutic products in the EU and in the US. Clara brings to the position a vision on the multiple regulatory environments applying of health products in their diverse forms and applications, and the understanding of the nuances and specificities of each these domains. This tranversality is a key asset for her to support her clients in navigating regulations for emerging and borderline products, as well as for building adapted approaches to support transition of products from one framework to another.
Within VCLS, Clara is responsible for developing and leading the Microbiome products regulatory expertise in both the medical (drugs incl. biologics and Live Biotherapeutic Products, medical devices, combination products) and food arenas. She is specifically in charge of projects involving microbiome-related technologies such as prebiotics-, probiotics- and postbiotics- based products, for which she coordinates the regulatory, nonclinical, clinical and CMC related activities. Clara participates to the development of regulatory science in that domain by building alternative regulatory paths for emerging products, developing interactions with regulatory agencies, and promoting awareness through expertise associations and working groups.
Prior to joining VCLS, and as part of her engineering degree, Clara worked for 6 months at RNI-Consulting (Angers, France), where she gained particular experience in the areas of food supplements and foods for infants and young children. During her time there, she had the opportunity to prepare, review and submit a number of regulatory notifications, assess the regulatory compliance of the composition and labeling of nutraceutical products, and develop appropriate nutrition and health claim development strategies for her clients. She also evaluated the global impact of the implementation of new EU food regulations on product global compliance.
Clara earned an engineering degree majoring in Sciences and Technologies of human biology, nutrition and food, at AgroparisTech (Paris Institute for life, food and environmental sciences), France. She also studied specialized food products in the University of Milan (Università degli Studi di Milano, Facoltà di Scienze Agrarie e Alimentari), Italy, as part of her engineering’s degree. Clara completed the RAPS training “Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals”.
Clara is based in France, in the Rennes office.
Associate Director, Medical Devices
As Associate Director for Medical Devices, Feza Haque is responsible for supporting companies in the development and implementation of global regulatory strategies for evaluation and marketing of their medical devices. This includes strategic positioning, roadmap developments and preparation (writing, reviewing and submission) of agencies consultations and regulatory files to support market authorization approvals of therapeutic products in the UK, EU and US. Feza brings to the role several years of experience in implementing medical devices regulation. During her time at the Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator for medicines, medical devices, and blood components for transfusion, she developed expertise in safety monitoring and leading projects involving a wide range of devices, including those used in bariatric, active neurological and cardiovascular, orthopaedic and wound care applications. She led the team responsible for safety monitoring of facial injectable and body contouring implants. Feza has acted as a product specialist in counterfeit device and falsified CE mark investigations, audits and inspections at Notified Body and manufacturer sites, assessment of clinical investigation and exceptional use authorisation applications, influencing regulation (UK and EU), drafting and reviewing communication publications by MHRA and UK Department of Health and Social Care, drafting information for press briefings and ministers, answering media enquiries and reviewing ISO standards texts.. As part of her stakeholder engagement activity, Feza has contributed to the work of MHRA expert advisory groups, represented MHRA at national implant registry meetings, held seat to inform the work of external stakeholder clinical advisory groups, presented at external conferences and acted as the key driver in establishing the regulator’s relationship with the UK aesthetic professional stakeholder community. She has also presented at virtual worldwide regulators’ meetings on her reactive and proactive device safety projects and investigations. Feza has also contributed on projects relating to internal risk management and triaging tools, IT and business intelligence systems, and internal procedures to enhance the signal detection capability for smarter working in safeguarding public health.Neighbors
Orixha
AIINTENSE
AiiNTENSE optimizes the management of patients with acute or chronic neurological pathology, more particularly peri-resuscitation or associated with covid-19.
Based on the automated collection of clinically relevant elements of the patient record, AiiNTENSE platform is able to assist in the diagnosis and treatment of neurological pathology as well as its prognostic evaluation and follow-up, using a multimodal platform that integrates a health data portal, cognitive assistants, a monitoring application and a tele-expertise and teleconsultation network. It allows hospitals to guarantee full traceability of procedures, to reduce bed occupancy time and to save medical staff time.
The platform integrates outputs of specialized medical devices and algorithms developed in collaboration with medical R&D centers.
CERTIS THERAPEUTICS
CERTIS THERAPEUTICS has developed minimally invasive therapy solutions based on real-time MRI guidance. The company is a spinoff from IHU Liryc (Bordeaux, France), a leading international institute focused on better understanding and treating cardiac electric disorders. Our technology aims to improve both the efficacy and the safety of thermal ablation treatments.
CERTIS THERAPEUTICS’ core technology has been validated on various organs and addresses cardiology, oncology, and neurology.
Pharmacodynamic Modeling and Artificial Intelligence
Paris, France
HILLO
Hillo develops the first AI-based decision support platform for diabetic patients, based on a blood glucose levels predictive system that adapts to every patient’s physiology and habits.
Our technology combines pharmacodynamic modeling and artificial intelligence, we develop tools for patients to help them anticipate and avoid hypo- or hyperglycemia, and for care teams to help them understand each patient’s specific glycemic response. We’ve demonstrated outstanding results and accuracy of our predictive technology through trials in hospitals.
AIVISION
AgenT
AgenT is on a mission to detect Alzheimer’s when it can be prevented through a simple blood test. To prevent the onset of symptoms or stop the progression, we need to diagnose Alzheimer’s long before dementia.
By combining multi-omics biomarkers signals with machine learning, AgenT identifies Alzheimer’s patients that no other current diagnostic tool can detect.
They envision a future where routine health screenings include a blood test for Alzheimer’s to slow down the disease’s progression before it’s too late.
Hemerion
Each year, in Europe and in the US, more than 20,000 patients undergo surgery for a brain cancer. This condition remains incurable, but the quality of surgery significantly improves survival. The combination of a photosensitizer drug and a laser illumination device makes it possible to treat disseminated and inaccessible cancer cells during surgery. This technology offers new perspectives and developments on brain cancer therapy are already under clinical evaluation.
The proof of concept is established, the absence of toxicity is demonstrated and the first trials in humans show an improvement in patient survival. In this context, Hemerion aims to market this new modality for 2026.
Glaucome
Paris, France
BIOPHTA
Lack of adherence to Rx eye drops is the #1 Unmet Medical need in Ophthalmology. Poor treatment compliance leads to a worse progression of Eye Diseases. We will change lives of patients suffering from chronic eye diseases by creating a best-in-class solution reducing treatments burden.
Bubble removal for safer intravenous infusion
Ireland
Gasgon Medical
Intravenous therapy is the most common invasive therapy in healthcare, with 3.7 billion disposable IV tubes used each year, and complications from air bubbles are frequent and present serious risks of adverse events for patients. Gasgon Medical is developing ALOTIS, a closed-system aspirator device to safely remove bubbles from IV drugs including toxic chemotherapy drugs, thereby protecting patients and healthcare workers from occupational exposure, a key initiative of the European Health policy makers. Gasgon has plans to enter the market in Europe by 2022, with clinical study plans in place through its hospital partners.
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