Publication date: 28/09/2018
In vitro diagnostics regulatory expert Qarad has been nominated twice by TOPRA, the European regulatory healthcare professionals organisation. Once for its innovative eIFU solution, a website where manufacturers make their instructions for use available to their users, and a second time for the individual contribution to the profession of principal consultant Maurizio Suppo for his 33-year track record of excellence. On November 1st TOPRA announces the winners.
Recognized for 10 years of pioneering in e-Labeling
In the Innovation category, TOPRA nominates firms or individuals that have successfully implemented innovative ideas in the field of Regulatory Affairs. Qarad already launched the 1st version of eIFU.online in 2008 and it became the reference in the market ever since.
“We have launched eIFU.online 10 years ago. The nomination by TOPRA recognizes our pioneering work in the digitization of the distribution of Instructions for Use for in vitro diagnostics and medical device manufacturers”, says founder and President Dirk Stynen, Ph. D.
33 years of excellence in Quality Systems and Regulatory Affairs
TOPRA has nominated Qarad’s co-owner Maurizio Suppo in the category ‘Contribution’ that recognises regulatory professionals who have made a significant contribution to a team, project, regulatory science or the profession.
“Our whole company is proud of Maurizio’s nomination. For us this highlights 33 years of excellence in quality systems and regulatory affairs”, states Dirk Stynen, Ph. D., Qarad’s founder and President.
Maurizio Suppo (°1960, Italian) obtained his Ph.D. in molecular biology from the University of Turin in 1985 and pursued a career in the field of Regulatory Affairs and Quality Systems. He was the director of the European Diagnostic Manufacturers Association (EDMA) and had a significant role in the development of the European IVD Directive 98/79/EC. Maurizio Suppo joined Qarad in July 2012 as Principal Consultant. He is a regular speaker and chairman at international conferences and has
published more than 20 articles in the specialized press.
Qarad is a Belgium based company offering Expert Consultancy in EU and US regulations for In Vitro Diagnostics (IVD) and Medical Devices (MD). Apart from regulatory consultancy, Qarad’s main services are the organization of Performance Evaluations for IVD and assistance in the implementation of Quality Management Systems according to ISO13485. Furthermore, Qarad is the Authorized Representative for a high number of non-EU based manufacturers of IVD and MD. A strong belief that new technologies should make our customer’s life easier, linked to an in-depth knowledge of IVD and MD regulations, resulted in the development of our eIFU services. We differentiate ourselves in the eIFU area by offering a single supplier solution, developed by regulatory experts with a focus on compliance and risk management. Qarad’s eIFU services are offered based on a configurable standard platform or as a tailor-made solution, both familiar to the Notified Bodies.
TOPRA is the professional membership organisation for individuals engaged in regulatory affairs for human or veterinary medicines and medical devices across Europe. TOPRA works with their members internationally to enable and promote excellence across the healthcare regulatory profession.