Elite Of Chaos Index du Forum
Elite Of Chaos Index du ForumFAQRechercherS’enregistrerConnexion

Active Implantable Medical Devices Directive Pdf Download

 
Poster un nouveau sujet   Répondre au sujet    Elite Of Chaos Index du Forum -> Demande diverse -> Candidatures
Sujet précédent :: Sujet suivant  
Auteur Message
renwash


Hors ligne

Inscrit le: 12 Mai 2016
Messages: 141
Localisation: Nice

MessagePosté le: Sam 3 Sep - 15:06 (2016)    Sujet du message: Active Implantable Medical Devices Directive Pdf Download Répondre en citant




Active Implantable Medical Devices Directive Pdf Download > bit.ly/2cnVHNG

























































bd40bc7c7a
(a),data,relating,to,registration,of,manufacturers,and,authorised,representatives,and,devices,in,accordance,with,Article,14,excluding,data,related,to,custom-made,devices;,(b),data,relating,to,certificates,issued,,modified,,supplemented,,suspended,,withdrawn,or,refused,according,to,the,procedures,,as,laid,down,in,Annexes,II,to,VII;,(c),data,obtained,in,accordance,with,the,vigilance,procedure,as,defined,in,Article,10;,(d),data,relating,to,clinical,investigations,referred,to,in,Article,15.,The,,EC,,declaration,,of,,conformity,,is,,the,,procedure,,whereby,,the,,manufacturer,,who,,fulfils,,the,,obligations,,imposed,,by,,Section,,1,,ensures,,and,,declares,,that,,the,,products,,concerned,,meet,,the,,provisions,,of,,this,,Directive,,which,,apply,,to,,them.,,If,individual,packaging,of,each,unit,is,not,practicable,,the,information,must,be,set,out,in,the,leaflet,supplied,with,one,or,more,devices.,2.6.,,in,Article,9,the,following,paragraphs,are,added:,,5.,

The,devices,must,be,designed,,manufactured,and,packed,in,such,a,way,that,their,characteristics,and,performances,during,their,intended,use,will,not,be,adversely,affected,during,transport,and,storage,taking,account,of,the,instructions,and,information,provided,by,the,manufacturer.,ARTICLE,,,13,,,-Decisions,,,with,,,regard,,,to,,,classification,,,and,,,derogation,,,clause.,,,The,,,notified,,,body,,,must,,,carry,,,out,,,the,,,appropriate,,,examinations,,,and,,,tests,,,in,,,order,,,to,,,verify,,,the,,,conformity,,,of,,,the,,,product,,,with,,,the,,,requirements,,,of,,,the,,,Directive,,,either,,,by,,,examining,,,and,,,testing,,,every,,,product,,,as,,,specified,,,in,,,Section,,,5,,,or,,,by,,,examining,,,and,,,testing,,,products,,,on,,,a,,,statistical,,,basis,,,as,,,specified,,,in,,,Section,,,6,,,,as,,,the,,,manufacturer,,,decides.,,,1.1b,The,clinical,evaluation,and,its,outcome,shall,be,documented.,In,the,case,of,devices,referred,to,in,Annex,I,,Section,7.4,,third,paragraph,,the,scientific,opinion,of,the,EMEA,must,be,included,in,the,documentation,concerning,the,device.,(a),,,the,,,name,,,or,,,trade,,,name,,,and,,,address,,,of,,,the,,,manufacturer.,,,13.1.,,In,the,case,of,devices,falling,within,Class,III,and,implantable,and,long-term,invasive,devices,falling,within,Class,IIa,or,IIb,,the,manufacturer,may,commence,the,relevant,clinical,investigation,at,the,end,of,a,period,of,60,days,after,notification,,unless,the,competent,authorities,have,notified,him,within,that,period,of,a,decision,to,the,contrary,based,on,considerations,of,public,health,or,public,policy.,If,,the,,batch,,is,,accepted,,,the,,notified,,body,,affixes,,or,,has,,affixed,,its,,identification,,number,,to,,each,,product,,and,,draws,,up,,a,,written,,certificate,,of,,conformity,,relating,,to,,the,,tests,,carried,,out.,,

brazil foreign policy pdf downloadpenanggulangan gunung meletus pdf downloadad 2000 w2 pdf downloadargente alvarez semiologia pdf downloadtattoo flash books pdf downloadferdinand marcos administration pdf downloadlibros para jovenes pdf downloadhrana za misice pdf downloadcore competency model of prahalad pdf downloadmeio ambiente e saude pdf download


Revenir en haut
Publicité






MessagePosté le: Sam 3 Sep - 15:06 (2016)    Sujet du message: Publicité

PublicitéSupprimer les publicités ?
Revenir en haut
Montrer les messages depuis:   
Poster un nouveau sujet   Répondre au sujet    Elite Of Chaos Index du Forum -> Demande diverse -> Candidatures Toutes les heures sont au format GMT + 2 Heures
Page 1 sur 1

 
Sauter vers:  

Index | Panneau d’administration | Creer un forum | Forum gratuit d’entraide | Annuaire des forums gratuits | Signaler une violation | Conditions générales d'utilisation
darkages Template © larme d'ange
Powered by phpBB © 2001, 2005 phpBB Group
Traduction par : phpBB-fr.com