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Hello All,
My name is Brett Rosenthal. I am a nineteen year old sophomore at the University of Maryland-College Park. I was recently hired to work quality control for my grandfather's company, but most importantly, get the paperwork ready for the changes of Directive 93/42/EEC due to Directive 2007/47/EC.
I have read both of the directives from the Official Journal of the European Union and reviewed much of the information on this website alongside other information I have found online. I have all of our audit information from G-MED CE audit we last had during last year in a binder.
To be completely honest, this is my first time dealing with any sort of quality control issues for a business and so far this task has overwhelmed me. There is only one other person in the building I work in with even ISO training (not that I know what that means) because the previous two Quality Control personnel recently left the company and I believe out of nearly all the employees I am best suited to comprehend this information, but to be completely honest after two days of alot of reading and little comprehending I was hoping someone could at least point me in the correct direction with this task.
Any pointers/information/guidelines would be more than appriciated. I can provide any pertinant information if it will help someone lend me a helping hand. I am working with Class I devices.
Thanks All,
--Brett Rosenthal
Edited because I changed the class from IIa to I after futher reading.
My name is Brett Rosenthal. I am a nineteen year old sophomore at the University of Maryland-College Park. I was recently hired to work quality control for my grandfather's company, but most importantly, get the paperwork ready for the changes of Directive 93/42/EEC due to Directive 2007/47/EC.
I have read both of the directives from the Official Journal of the European Union and reviewed much of the information on this website alongside other information I have found online. I have all of our audit information from G-MED CE audit we last had during last year in a binder.
To be completely honest, this is my first time dealing with any sort of quality control issues for a business and so far this task has overwhelmed me. There is only one other person in the building I work in with even ISO training (not that I know what that means) because the previous two Quality Control personnel recently left the company and I believe out of nearly all the employees I am best suited to comprehend this information, but to be completely honest after two days of alot of reading and little comprehending I was hoping someone could at least point me in the correct direction with this task.
Any pointers/information/guidelines would be more than appriciated. I can provide any pertinant information if it will help someone lend me a helping hand. I am working with Class I devices.
Thanks All,
--Brett Rosenthal
Edited because I changed the class from IIa to I after futher reading.
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