dispositifs médicaux

La frontière entre dispositifs médicaux, médicaments et produits combinés se réduit de plus en plus. La publication du règlement européen 2017/745, modifie en profondeur le contexte du développement, de la [...]

While the industrial sector and the general public have already moved into digital technology, the health sector hasn’t yet undergone its digital revolution.Even with the presence of regulatory and prescriptive restrictions in [...]

Original article (IN FRENCH)         This is an article of information and opinion about the emergence of new technologies in the health world.   Summary: 1. Introduction: [...]

Already present in many fields for several years and even decades, Computer-aided drafting (CAD) is increasingly used in the Medical Devices industry.  Firstly, defining a design in the conceptualizing process: getting a [...]

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 [...]

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 [...]

  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 [...]

Responsibility needed for medical device manufacturers for the protection of personal data The European Regulation 2016/679 of 27 April 2016[1] introduces a new regulation on the processing and circulation of personal [...]

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 [...]

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 [...]

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 [...]

  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 [...]