New Job and I could use any pointers or tips on 2007/47/EC

[bjr990]

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.

[jkuil]

I hope this training I made helps

[bjr990]

that was alot of help and much easier to comprehend, thank you.

I was wondering if someone could clarift for me that Automatic electronic sphygmomanometer and body composition analyzers would fall into Class I as per Rule 12 of Annex IX

[bjr990]

Also, if i uploaded my DofC would someone be kind enough to take a quick gander at it and let me know if it's good to go.

[Wes Bucey]

In Reply to Parent Post by bjr990

Also, if i uploaded my DofC would someone be kind enough to take a quick gander at it and let me know if it's good to go.

There are always folks here in the Cove willing to review such documents and offer comment. If you have trouble uploading, contact Marc at http://elsmar.com/Forums/sendmessage.php

[bjr990]

Thank you, I have attached my DofC although after reviewing MEDDEV I believe the blood pressure cuff puts me in Class IIa. Thanks for whoever has the time to take a gander at it.

Note: I did try to update it, I just have not changed the filename yet

[Persson - 2010]

In Reply to Parent Post by bjr990

Thank you, I have attached my DofC although after reviewing MEDDEV I believe the blood pressure cuff puts me in Class IIa. Thanks for whoever has the time to take a gander at it.

Note: I did try to update it, I just have not changed the filename yet

I am very curious about how you could classify in the DoC your product " HealthGuard-15 Blood Pressure & Body Fat Measurement System" as Class I device. Most of the Blood Pressure Meters fall in Class IIa.

[Persson - 2010]

In Reply to Parent Post by bjr990

Also, if i uploaded my DofC would someone be kind enough to take a quick gander at it and let me know if it's good to go.

There is a Thread discussing specifically about the required content of the Declaration of Conformity. It may help you.
http://elsmar.com/Forums/showthread.php?t=23799