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.
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.
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.
Director, Medical Devices
As Director, Medical Devices, Phil is responsible for providing SaMD consulting expertise to VCLS clients with Medtech in design and implementation of international regulatory strategies, from early stage proof of concept, through to development and placing on the market achieving efficient Product Realisation.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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