| Health |
Consultancy -HealthYou are in the area of Health You search: - to give a service of dependable and of quality Quasys gives you: - his methodology and its experience to set up a quality system with the aim of: - meet the Good Practices of Manufacture (BPF, GMP) - in according to Directives 93 / 42 / European Economic Community, 98 / 79 / this answer requirements in the hospital area - a booklet of information concerning the medical implements, MDD Information - a service of Recognised Deputy - to meet needs of Producers of medical implements except Europe - a service of regulation business, thanks to - her affiliation to professional associations she participated MDD Information Inform you about the last updatings and interpretations of directives relating to the medical implements (90 / 385 / European Economic Community, 93 / 42 / European Economic Community and 98 / 79 / this) MDD INFORMATION is a booklet of synthesis edited twice a year it is information on the review of directives, new versions of norm ISO 13485, new classifications, tendencies
QUASYS gives you a service of Presentation intended for the producers except Europe of medical implements in accordance with requirements of Directive 93 / 42 / European Economic Community Role of the Recognised Deputy The Producers located except Europe have to name a Recognised Deputy or an importer to fill certain requirements of Directive 93 / 42 / European Economic Community before marking IT. 1. Lawful aspects • Name and address of the Recognised Deputy must be mentioned on the tab of the product and/or in instructions. This puts in an obvious place the lawful link which exists between the Producer and the Recognised Deputy. The Recognised Deputy is responsible for the presentation of the Producer to European Competent Authorities and to all European organisms of Business rules. • name and address of the Recognised Deputies must be included in Statement IT of Compliance. • The Recognised Deputy is made to provide Reports of Alertness on the Medical Implements as for the Producer. Any not respect for lawful expiry dates, or quite other breach can drive to lawful sanctions as well contrary to the Deputy that of the Producer. The Recognised Deputy, his nomination and its duties must be specified by contract. • The Recognised Deputy is an external and vital element of the Quality system of the Producer and should be signalled in the Manuel de Quality of producer as well as in procedures. • The Recognised Deputy can have to confront claims as for his responsibility if he does not carry out his lawful commitments correctly. 2. Other obligations • The Recognised Deputy must know requirements of the national Member State (when it is of application) besides requirements of Directive. • The Recognised Deputy must have a team enough skilled and formed to be able to answer national requirements and make initial decisions as for the Producer. 3. Why to name a Recognised Deputy when a Distributor can fill this function free? • to hire a Distributor among others can draw away an organization into a hierarchy of the Distributors and from there a feeling of faintness for those who are not indicated. The obligation to include name and address of the Distributor named on tabs is an advantage for this one and a huge disadvantage for other Distributors. • It is sometimes difficult for a Distributor to remain neutral and he could make decisions which would be opposite to the international commercial objectives of the Producer. • to Name a Distributor can possibly cost of time and silver if the Producer likes to change Distributor. Besides, products mentioning the name of the original Distributor risk staying in the retailing chain for a long time. • A Distributor called has access to the files of the product. Do not forget that this Distributor can become one day, your rival! Quasys - www.quasys.com - information [at] quasys.com - BE 0439.990.911 |
