April 19th, 2013
On April 19th, 2013 Dr. Dirk Stynen and Chantal Huysmans will give a presentation at the 2nd Annual European Medical Device Regulation Conference in Brussels, Belgium. Dr. Dirk Stynen, President and Principal Consultant at Qarad, and Chantal Huysmans, our International Sales Manager, will provide attendees at this conference with a clear picture on the challenges and benefits of the E-labeling Services in Europe.
With Europe being composed of numerous nations, languages and dialects, the hurdles in developing and distributing medical device instructions for use in paper format are critical. In reply to the demand for a more uniformed labeling process, the European Commission issued the Electronic Labeling for Medical Devices draft in 2011, followed by the commission regulation n° 207/2012 providing guidance to manufacturers on how to update labeling operations and most importantly deliver labels in electronic format. While underlying opportunities and benefits in electronic format labels are undeniable for the industry, it remains very important for regulatory affairs executives to clearly understand this new requirement to ensure a successful implementation.
Qarad’s team will address three main regulation and implementation challenges at this conference;
At the same conference, Dr. Dirk Stynen will act as moderator for the panel discussion “What to Expect with the New Notified Body Environment in Europe”.
With new sets of rules for European notified bodies as well as shifts in their roles and responsibilities, the medical device industry is eager to know more about the challenges and opportunities ahead in working with these bodies. During the panel, notified bodies and industry will have the opportunity to discuss the following items and how they will impact the overall collaboration;
April 2nd, 2013
We are pleased to announce that Chantal Huysmans has recently joined our team. Chantal will act as Qarad's International Sales Manager and will focus mainly on our Qarion E-labeling Services. Chantal will also consult manufacturers about Quality Systems.
Chantal's expertise with Quality Systems and the ISO 13485 standard will strengthen Qarad's team. For the past 11 years, Chantal has held the position of Quality Manager for DiaMed Benelux, a division of BIO-RAD. Chantal established and managed the company's Quality System according to the ISO 13485 standard.
Furthermore, Chantal has good commercial insights and is a good negotiator. She obtained 15 years of experience as a Technical Sales Service Supporter while working for Avery Dennison. Her open manner of communication has allowed her to start up and maintain many successful business relationships. She also speaks several languages fluently.
Chantal will now mainly focus on promoting our E-labeling Services. The multilingual Instructions for Use are often expensive, take up a lot of space in the kits, are difficult to keep up-to-date and are extremely user-unfriendly since they need to be printed in a small illegible font. MEDDEV 2.14/3 now offers the manufacturers of IVDs the opportunity to make the Instructions for Use available by alternative means. The fact that your documents are made available online has many advantages. However, these documents need to be placed in a controlled environment that adheres to the European regulations described in the guidance document MEDDEV 2.14/3. Qarad recently launched its first product, namely the Qarion E-labeling website, which adhere to all these regulations. Chantal will manage this website and will advise manufacturers about the benefits of the Qarion E-labeling website.
Dr. Dirk Stynen & Chantal Huysmans will present the challenges & benefits concerning E-labeling Services in Europe
April 18-19, 2013
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