EN

  • EMC3 Consulting
  • MedTech Momentum
  • I-care
  • Actolis
  • Lifetech Brussels
  • Meddeva
  • MDI Europa
  • Soladis
  • UseConcept
  • Axeme Conseil
  • Neomed Services
  • Orion
  • Qualitiso
  • Ehealth HUB
  • Baehl Innovation
  • Bignon & Lebray
  • CILCare
  • Delsol Avocats
  • Ebma
  • Eurofins Optimed
  • France Biotech
  • French Medical Alliance in Korea
  • i4CT
  • Icosa
  • In Extenso Innovation Croissance
  • IODA
  • IQVIA
  • SGS
  • AKKA LIFE SCIENCE
  • ARCHIMED
  • AXONAL
  • Enterprise Ireland
  • Kobridge Consulting
  • LOK North America
  • Net-Translators
  • BPI France
  • Eurobimed
  • LyonBioPôle
  • KEY2COMPLIANCE
  • Audit & Risk solutions
  • MEDICEN
  • Informations pratiques
  • EMC3 Consulting

    MedTech Momentum

    MedTech Momentum is a full-service marketing firm, 100% specialized in the Medical Industry. The companies has a proven track-record, with companies of all sizes, at branding, creating awareness, and generating qualified leads, using the power of Online Marketing, Social Media and Pay-Per-Click advertising.

    I-care

    The i-Care Cluster brings together health technologies players from the Rhône- Alpes region (medical device, e-health solution, autonomy & silver economy).

    By its knowledge of the sector and of the mutations under way, the i-Care Cluster helps regional ecosystem (companies, research centers, health facilities, etc.) collectively grasping the current health issues : organizational (outpatient, home care, care pathways, etc.), medico-economics (clinical evaluation, hospital purchases, export), regulation (CE marking, FDA, emerging markets) and societal (aging, patient- actor, prevention).

    Actolis

    Actolis is a consulting organization for life sciences companies ( medicines, medical devices, cosmetics).
    The team has an extensive experience of pharmaceuticals regulations and important technics skills. Main missions are : qualification/validation, shop floor revamping, quality assurance, project management, change management, audits and training.

    Our customers are R&D, production, dispatching or headquarters sites; they are operators or sub-contractors.

    Lifetech Brussels

    lifetech.brussels is the health cluster of the Brussels-Capital Region gathering more than 100 members (companies, public instances, universities and start up incubators, different stakeholders in private and public financing, R&D centres, sectorial federations, experts, and a variety of support organisations) active in the biotech, pharma, medical devices, digital health and active ageing sectors.

    The cluster supports the life technologies sector by providing to its members individual and collective services.

    It ensures that life technologies remain a strong driver of economic growth in the region and attracts new R&D companies and investors, by increasing the visibility of the Brussels know-how, stimulating innovation, encouraging international partnerships and generating synergies between the players.

    Connect with us on LinkedIn, Twitter, Facebook.

    Meddeva

    Meddeva offers a wide range of expertise providing support in the development of your projects in their technical, clinical and regulatory dimensions.

    Fully understanding the environment of medical devices, Meddeva offers you a new approach to outsourcing innovation to improve your performance and meet your compliance objectives.

    MDI Europa

    MDI Europa was created in 2000 to provide high quality regulatory affairs services. Our customers are manufacturers, importers, exporters and distributors of medical devices and in vitro diagnostics world-wide.

    Our high quality compliance solutions, as confirmed by our ISO 9001 : 2008 certification, include classification, identification of EU standards, technical Documentation compilation and review, EU Authorized Representative, product registration to national EU Authorities, Labeling Compliance, Free Sales Certificates, market research, translation services, and more.

    Soladis

    Founded in 2000, Soladis is a services and consultancy company specialized in applied statistics and biostatistics and supporting activities of RDI (research, development, innovation), industry / production and marketing departments. The company proposes its services to clients from SMEs to large account.

    The company developed its expertise in the "Life Science" area where Soladis committed since its establishment, and strengthen its offer in time to propose support services for clinical research.

    The take-over of a 20 years experienced company in 2015 enabled Soladis to expand its skills spectrum with the integration of a medical head, scientific writers, data managers (eCRF Management and Data Management), and data entry operators (clerks).
    Thanks to the completion of its statistical knowledge with a new and related know-how and expertise, Soladis became a reference player in the field of clinical research, providing full support of clinical studies.

    Henceforth, the company proposes an intervention from the protocol’s definition to the scientific publication in a review, taking care of the hiring needs (patients/doctors), the data capture, the logistic, the monitoring…

    Soladis intervention steps are the following:

    - Medical writings of the launched studies, with a reliable intervention on the protocol side and questionnaires (CRF,eCRF)
    -  The report submission to the French authorities with the structures : CCTIRS, CNIL,CNOM and in the other countries with the BPharm.
    - The launching of projects including the sites qualification/RC centers, the hiring of doctors      and patients, and the management of the financial agreements.
    - Taping data, data management plan and data validation document.
    - Clinical trial monitoring
    - Data management

    - Database freeze
    - Statistical report combining medical and statistical expertise.
    - Clinical report under ICH according to the sponsor model
    - Publications/articles/posters

    UseConcept

    UseConcept is a new company located in Eurasanté (2 hours by train from London and Brussels) with a fresh approach to ergonomics and usability. Our human factor experts specialized in usability have 20 years combined experience in the health care sector. The Useconcept offer supports the overall design process and we assist our clients to design a relevant, intuitive and safe product.  As a result, the adoption of their solutions is significantly improved.

    UseConcept is the only French company specialising in a user centered design process for E-Health and medical devices. We help our clients to be compliant with the EN ISO 62366 and EN60601 standards.

    Axeme Conseil

    Axeme Conseil is an Executive Search Agency specialized in the Medical Technology and Life Sciences fields.

    We are based in Paris, and our Clients are active in these fields in France and in Europe.
    For the past 10 years, AXEME Conseil has specialized in top and middle-level management, as well as Sales, Marketing and Support (Clinical, Quality, Regulatory, Technical, R&D) position assignments for a wide variety of Clients, including international groups, mid-cap and start-up companies.

    AXEME Conseil seek to achieve a sincere partnership with our Clients, through an excellent level of thoroughness, professionalism and ethical conduct that we extend equally to the European Candidates we work with.

    Neomed Services

    NEOMED Services assists you in design, validation and regulation of all your medical devices. Our company is providing you custom, concrete and sustainable solutions to your technical and regulatory issues. NEOMED Services team integrates complementary areas of expertise to meet all your needs. From design to market launch and post-market monitoring to industrialization, we offer our services throughout your project or on specific issues.

    Orion

    Orion Medical Innovations is a US-based company specialized in supporting and promoting safe, high-tech and advanced medical devices, equipment and supplies covering many regions around the world in Europe, Middle-East, South-East Asia and the USA.

    Very selective and always targeting the most innovative products in our portfolio, through a professional network of local partners around the globe, we are able to provide a consistent and high level of service to end-users. 
    Our mission is to make a difference in people's quality of life with safe and cutting-edge technologies.

    Qualitiso

    Blog of Guillaume Promé, one of our experts, on the new medical device regulation.
    Numerous resources available for manufacturers for free : analysis of applicable texts, practical guidelines, online tools, agenda of events in the industry, ...

    Ehealth HUB

    Baehl Innovation

    Bignon & Lebray

    Depuis 1982, nous développons les compétences de nos équipes dans tous les domaines du droit des affaires.

    Notre cabinet réunit plus d’une centaine de professionnels, dont 25 avocats associés, organisés en 11 pôles d’expertise.

    La diversité culturelle et professionnelle de nos collaborateurs est le reflet de notre histoire : celle d’un cabinet d’avocats français indépendant qui a su accompagner ses clients et évoluer dans un contexte chaque jour plus innovant et international.

    CILCare

    Delsol Avocats

    Ebma

    Eurofins Optimed

    France Biotech

    French Medical Alliance in Korea

    i4CT

    Icosa

    In Extenso Innovation Croissance

    IODA

    IQVIA

    SGS

    AKKA LIFE SCIENCE

    ARCHIMED

    AXONAL

    Enterprise Ireland

    Kobridge Consulting

    LOK North America

    Net-Translators

    BPI France

    Eurobimed

    LyonBioPôle

    KEY2COMPLIANCE

    Audit & Risk solutions

    MEDICEN

    News
    Liens utiles
    md101 - medical devices consulting from france
    Affaires réglementaires 

    Vous avez conçu un produit et utilisé sur le terrain à des fins de recherche clinique ou dans un environnement clinique simulé. Vous êtes désireux d’obtenir les autorisations de placer votre produit sur ​​le marché pour une utilisation clinique réelle.
    Nous vous aidons à passer à travers les phases obligatoires pour obtenir une autorisation de marché aux États-Unis ou en Europe: