Consulting	^
	Qarad’s consultants will assist manufacturers in achieving compliance with the European Directives for Medical Devices and In Vitro Diagnostic Medical Devices. This will lead to the CE-marking of these devices and give them a passport to the European market.   Qarad also helps companies with the implementation or improvement of quality systems based on ISO13485, FDA QSR (21CFR820), ISO17025, ISO15189 or ISO9001.   For a complete overview of offered services, following the appropriate link: medical device manufacturers in vitro diagnostics manufacturers personal protective equipment manufacturers (medical) test laboratories
	Authorized Representative	^
	Non-European manufacturers of medical devices (MD), in vitro diagnostic (IVD) medical devices and other products such as personal protective equipment (PPE) may have to appoint an Authorized Representative in Europe if they want to place their products on the European market. The appointment of an Authorized Representative is mandatory for all IVDs, Class I MDs and PPE. It will soon become mandatory for all MDs, irrespective of their classification. Qarad offers Authorized Representative services with an added value. Its consultants and staff have a long industrial experience, not only in functions in regulatory affairs and quality assurance, but also in R&D. They have the professional skills to represent your interests in Europe and effectively communicate with national authorities and notified bodies. For more information, go to the Authorized Representative page.