CLASSify identifies the correct product class for a medical device for CE Marking quickly and accurately with just a few clicks – making it an essential tool for the regulatory professional seeking to determine, confirm or simply check the class of a medical device to be placed on the European market. As such, it may be used at all times to provide guidance at crucial stages of product development, regulatory processes and market placement.
Information produced by CLASSify can be viewed in both graphical and textual modes. The CLASSify classification chart tool is a graphical representation of a medical device’s classification consistent with the rules described in Annex IX to Directive 93/42/EEC (as amended). Users can also select the level of classification required, and in its most in-depth setting, CLASSify is designed to examine each property of an eligible medical device according to its mode of contact with the human body, duration and nature of contact.
After registration, users enter all relevant information into the CLASSify website and can request a customised report encompassing all information on a specific product, its class and relevant regulatory framework information. There is also a simple Classify Checklist available containing basic, relevant information on the specific device and class.
About CLASSify
CLASSify is the first on-line classification portal designed to provide users with a simple tool for classifying their medical devices in accordance with the rules of the European Medical Devices Directive 93/42/EEC, as amended. Conceived and developed by professionals with decades of experience, familiarity and knowledge of European classification, the website was engineered by regulatory specialists and experienced programmers following a thorough analysis of the classification rules, opinions and other information sources. The classification determined with the help of CLASSify does not, however, constitute an opinion or judgement by the European Commission.
About Quality First International
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. Clients who follow the guidance from QFI have never been turned down and have always received approvals on the first submission. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
For further information please contact
Marija Capek
Quality First International
Tel: +49 (0)176 212 444 26
http://www.qualityfirstint.com
