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SPOTLIGHT #5

25 juillet 2016
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 [...]Read more

Tech & Health

18 juillet 2016
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: [...]Read more
Computer-Aided Drafting ( CAD) in Medical Devices Industry

CAD in Medical Devices Industry

18 juillet 2016
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 [...]Read more

SPOTLIGHT #4

7 juillet 2016
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 [...]Read more

The Launch of our Quality Management System

4 juillet 2016
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 [...]Read more

Spotlight #3

21 juin 2016
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 [...]Read more

SPOTLIGHT #2

21 juin 2016
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 [...]Read more

Spotlight #1 - access to european market

3 juin 2016
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 [...]Read more

STING - Go Global Medtech Program

1 juin 2016
  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 [...]Read more

Going International Before Obtaining Your CE-MARK

23 mai 2016
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 [...]Read more

MD101 on the web

21 avril 2015
MD101 Consulting continues its expansion and promotes the launch of its newly designed website - www.md101consulting.com. Today comprised of 12 experts in France, 15 worldwide and 25 partner companies, we [...]Read more

DM Experts and Axeme Conseil

21 avril 2015
MD101 Consulting partners with DM Experts and Axeme Conseil to launch a new innovative event in the field of life sciences - the RDV Experts Medtech taking place in Paris (France) on 28 [...]Read more

MD101 and Imagilys

20 avril 2015
MD101 assists for quite some time now the company Imagilys, that designs and develops advanced neuroimaging software solutions. Mr. Mathieu Charleux, in charge of the international business development for clinical [...]Read more

MD101 and Vial Momentum

19 avril 2015
MD101 Consulting and Vial Momentum have decided to team up to bring extensive services to their clients - medical device manufacturers. "The complementarity of our services and the geographical reach [...]Read more

Pole Medicen Paris Region

8 avril 2015
MD101, in partnership with Actolis, hosted March 19, 2015 at the Pole Medicen Paris Region a morning workshop session on regulatory issues related to software medical devices. Current issues were discussed, [...]Read more

The conference on connected e-health

19 mars 2015
MD101 Consulting was present at the conference on connected e-health organized by the Club Santé Bourgogne. The opportunity for our expert Mr. Guillaume Promé to share his expertise on the [...]Read more

MD&M West Conference 2015

18 février 2015
MD101 Consulting participated at the MD&M West Conference 2015 in Anaheim (Ca, USA) on 10-11 February 2015 and had the pleasure of meeting with local medical device manufacturers as well [...]Read more

MD101 and BIOCOM

16 février 2015
Our President, Mr. Mathieu CHARLEUX, recently was invited to make a presentation in front of 25 companies part of the BIOCOM medical cluster in San Diego thanks to FrenchBioBeach and [...]Read more

MD101 and Innov'Spine

2 décembre 2014
MD101 Consulting has been working in close collaboration with Innov'Spine, manufacturer of advanced solutions for spine surgery to develop its distribution network. Over the past year and a half, distribution [...]Read more

TechDays Santé Congress

25 septembre 2014
MD101 Consulting participated for the 1st time at the TechDays Santé congress in Lyon (France) on 23 September 2014. A good opportunity to meet with part of the team on [...]Read more

ISO/DIS 13485 Part 2

4 août 2014
New clause 4.1.6 The clause says:The organization shall document procedures for the validation of the application of computer software used in the quality management system, including production and service provision. [...]Read more
ISO/DIS 13485 : 2014 strengthens requirements about software - Part 1

ISO/DIS 13485 Part 1

4 août 2014
ISO/DIS 13485:2014 is the draft of the next version of ISO 13485. The final version should be published in 2015.This new version brings a lot of new requirements for management [...]Read more