ISO 9000:2000 and ISO 13485:2003 impact on the MDD 93/42/EEC

[ISO MAN]

Dear All,
I have been looking for any document to highlight the impact of the revision fo both ISO 9001:2000 and ISO 13485:2003 on the medical device directive. If anyone knows the changes to the MDD that are result to this change please share it.

Thanks

 

[Al Rosen]

Dear All,
I have been looking for any document to highlight the impact of the revision fo both ISO 9001:2000 and ISO 13485:2003 on the medical device directive. If anyone knows the changes to the MDD that are result to this change please share it.

Thanks

I don't believe that there is any change to the MDD. The MDD doesn't even specify what quality standard to use, but ISO 13485 addresses the requirements within the MDD that ISO 9001 does not.