FDA Medical Device User Fee 2018

Starting with FDAs Fiscal Year (FY) 2017, beginning October 1, 2017, the annual establishment registration and payment of the annual fee is due for every medical device establishment registered with the FDA.

The registration fee for the FY2018 is US$ 4,624.- and must be paid at the latest by December 31, 2017, otherwise, the registration status is suspended until the appropriate fee has been paid.

Of course we support you with the annual registration process - please contact us in case of questions, we are looking forward to provide our service to you.

Press release: MEDAGENT is one of the TOP 100

Firm from Mühlheim joins Germany's elite group of innovative companies / Award to be presented by TOP 100 mentor Ranga Yogeshwar.

Mühlheim - The 23rd TOP 100 awards for Germany's most innovative SMEs are about to be presented, and this year, MEDAGENT GmbH & Co. KG is joining this elite group. The Mühlheim-based firm took part in a rigorous, scientific selection process that analysed innovation management and successful innovation. Ranga Yogeshwar, the competition mentor,  presented the top innovators with their awards at the German SME Summit in Essen on 24 June.

MEDAGENT GmbH & Co. KG was particularly commended for its creative working environment. The company provides support for manufacturers of medical devices on regulatory and legal issues. Franz and Nicole Menean, who run the company together, give their employees the freedom to gain experience - and to make the odd mistake. The two managing directors believe it is very important that the team critically examines all of the processes, and itself, on a regular basis. "We listen to every suggestion and decide as a team whether it is a good idea or whether we want to take another approach," says Franz Menean.

MEDAGENT's 15 employees work together in two open-plan offices, making it easy for them to communicate with each other in peson. And, the doors to the management team's office are always open for everyone. This good working atmosphere is paying off: The TOP 100 company was founded in 2000 and is one of the frontrunners in its sector, both at a national and international level. In addition to the head office in Mühlheim an der Donau, the family firm also has sites in the United States and Brazil.

This year, more than 4,000 companies registered an interest in taking part in the TOP 100 competition, with 366 of them applying for the qualification round and 284 getting through to the finals. Ultimately, 238 made it into the TOP 100 (maximum of one hundred in each of the three size categories). Once more, the companies were evaluated by Nikolaus Franke, Professor of Entrepreneurship and Innovation at the Vienna University of Economics and Business Administration, and his team. They examined more than 100 parameters in the following five assessment categories: 'Innovation-friendly Senior Management', 'Climate of Innovation', 'Innovative Processes and Organisation', 'Innovations Marketing' and 'Successful Innovations'.

The TOP 100 are among the pacesetters in their sectors. Statistics reveal that the evaluation process included 97 German market leaders and 32 global market leaders. On average, they generated 40 per cent of their recent revenue from innovations and product improvements, which they brought to the market before their competitors. Their revenue growth rate was 28 percentage points higher  than the average for their industries. In the last three years, these SMEs have together applied for a total of 2,292 German and international patents. This ability to innovate also pays dividends in terms of jobs, with the TOP 100 planning to take on around 9,500 new employees in the next three years.

The TOP 100's mentor, science journalist and television presenter Ranga Yogeshwar, is impressed by the quality of the companies and hopes they will become role models. "The way in which the TOP 100 companies generate new ideas and develop groundbreaking products and services based on them is remarkable in the truest sense of the word. I am delighted that the award highlights these qualities. I hope their success will encourage others to follow in their footsteps, because this culture of innovation is going to become increasingly important for all companies."

Further information can be found:

TOP 100: http://www.top100.de/die-top-innovatoren/detail/medagent-gmbh-co-kg.html

DeviceMed: http://www.devicemed.de/18-medtechfirmen-zeigen-wie-innovationen-entstehen-und-wie-man-sie-vermarktet-a-540412/