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SPOTLIGHT #4

The number of start-ups is increasing across the globe, and in France more than anywhere else. We can even talk about it as a “Startup Nation”, with 20 000 start-ups across the country, 12000 in the Ile-de-France region and 3000 in Paris. We have an innovation cluster trying to transform tomorrow’s world, and start-ups are …

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The Launch of our Quality Management System

The main reference of all efficient organizations is the ISO 9001 standard. It is implemented by more than one million companies worldwide. The last version of the standard ISO 9001:2015 brings to organizations a more modern vision of quality assurance, pragmatic, dynamic, and more focused on expectations of organizations. This new version also brings new …

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Les Rendez-vous Experts Medtech à Strasbourg

Le 9 juin 2016 à Strasbourg s’est tenu au sein de la pépinière Ph8 la sixième édition des Rendez-vous Experts Medtech. Cet événement a rassemblé au total 23 entreprises et 6 experts. Dans un premier temps, les participants ont pu assister à deux présentations,  « Le nouveau MEDDEV sur l’évaluation clinique : comment s’y préparer »  par Anne-Laure BAILLY …

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SPOTLIGHT #3

Responsibility needed for medical device manufacturers for the protection of personal dataThe European Regulation 2016/679 of 27 April 2016[1] introduces a new regulation on the processing and circulation of personal data. It repeals Directive 95/46 / EC of 24 October 1995 which is the European reference text with regards to protection of personal data. If most …

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SPOTLIGHT #2

In general, a clinical evaluation is expected for any device regardless of risk category. Clinical evaluation of a MD is completed before it is placed on the market and throughout its lifetime. Clinical evaluation may take different forms and you can conduct clinical investigations for your device. Many people mistakenly think that the design of clinical trials …

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Ireland : the unexpected land of medical devices in Europe

There are still quite a few people in the medical device arena that are not fully aware of the vast ecosystem in place in Ireland. And I have to admit, I was one of them. Let’s tell the truth – yes there are many sheep, pubs (with nice music by the way) and churches in Ireland. …

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Spotlight #1 – access to european market

Have you ever considered selling your products in Europe? With over 500 million people, it’s one of the biggest and most important markets in the world. So far so good, but have you had the chance to directly liaise with one of the numerous authoritative bodies? One of the big downsides of the European market is its overwhelming …

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STING – Stockholm Innovation & Growth organizes a « Go Global Medtech Program » for young Swedish companies.

See http://www.stockholminnovation.com/en/our-programs/go-global-medtech/ This program is partly sponsored by European funding and by participating companies. During the last session on May 18-19, I had the honor of being chosen to present the specifics of the French Health system and Market Access in the context of medical technologies, including E-Health. A UK consultant also did a very interesting …

STING – Stockholm Innovation & Growth organizes a « Go Global Medtech Program » for young Swedish companies. Lire la suite »

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Going International Before Obtaining Your CE-MARK

A review of the recent developments made by Clarteis, an innovative company in the area of dermatology.   Typically, medical device start-ups develop a product in connection with their end users (most often on their own, unfortunately), they then raise funds, adjust the product from prototype to an industrialized device that is safe for patients, …

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La tournée Française des RENDEZ-VOUS EXPERTS MEDTECH continue !!

Suite aux 3 premières éditions en 2015 sur Paris, Grenoble et Lille avec leurs 99 participants, les co-organisateurs que sont Axeme, DMExperts et MD101 ont décidé de continuer la tournée Française des Rendez-Vous Experts Medtech en 2016 afin qu’ils deviennent un événement incontournable dans le paysage Français pour les entreprises du dispositif médical. « Nous allons à la rencontre des entreprises pour …

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Formation MD101 – revêtement implant et ISO11137

Pour avoir les détails de la formation, veuillez télécharger le PDF. SOMMAIRE : SESSION 1 : La projection Plasma d’Hydroxyapatite et de Titane sur implants Horaires : 09h00 – 12h30 — 14h00 – 17h30 Objectifs : Être capable d’appréhender de manière critique un procédé de projection plasma Moyens pédagogiques : Exposé – Études de cas pra- …

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Medic@lps fait son petit-déjeuner

Assistez au Petit-Déjeuner MEDIC@LPS, animé par Johann BONAMI du réseau d’experts santé MD101 sur le thème de la stérilisation des dispositifs médicaux. Cette présentation a pour objectif de faire un tour d’horizons des exigences relatives à la validation du procédé de stérilisation d’un dispositif médical à l’Oxyde d’Éthylène selon la norme ISO 11135 ou à la Chaleur …

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