E endlesslovehv Oct 20, 2010 #1 Oct 20, 2010 #1 What conformity assessment choices do you see for a company that intends to market a Class IIa device, but would like to use a contract manufacturer?
What conformity assessment choices do you see for a company that intends to market a Class IIa device, but would like to use a contract manufacturer?
bio_subbu Super Moderator Oct 20, 2010 #2 Oct 20, 2010 #2 Re: Conformity assessment choices for a contract manufactured Class IIa device endlesslovehv said: What conformity assessment choices do you see for a company that intends to market a Class IIa device, but would like to use a contract manufacturer? Click to expand... There are two choices for class IIa) products, 1. Annex VII (EC declaration of conformity and availability of technical documentation for authorities) 2. Annex II ( Full Quality Assurance system) I request you to refer the existing thread “Conformity Assessment Route from the Medical Devices Directive (93/42/EEC) Help”
Re: Conformity assessment choices for a contract manufactured Class IIa device endlesslovehv said: What conformity assessment choices do you see for a company that intends to market a Class IIa device, but would like to use a contract manufacturer? Click to expand... There are two choices for class IIa) products, 1. Annex VII (EC declaration of conformity and availability of technical documentation for authorities) 2. Annex II ( Full Quality Assurance system) I request you to refer the existing thread “Conformity Assessment Route from the Medical Devices Directive (93/42/EEC) Help”