Declaration of Conformance

[greg-westnine]

For our medical device registration we require to sign the legal document which asserts that the Open Voice Factory product is a class I medical device which complies with the relevant regulation.

[joereddington]

Next action is to write our our own form of words and then put it in a document.

[joereddington-public]

"The content of the Declaration of Conformity is described in GHTF/SG1/N40:2006 Principles of Conformity Assessment for Medical Devices."

[joereddington-public]

Our form of words

I, Joseph Reddington, Chief opperating office of eQuality Time declare that the Open Voice Factory software, which is hosted at http://www.theopenvoicefactory.org/ complies with the applicable Essential principles for Safety and Performance, has been classified as a class 1 device acccording to the classification rules and has met all the applicable conformity assessment elements.

I need the GMDN code this page suggests that it is "Voice synthesizer/digitizer", and that's good enought for me, but I've also registered as an academic research on the GMDN website as well.

The Open Voice Factory's GMDN code is "Voice synthesizer/digitizer". It is of Risk Class A according to Rule 12 of the Principles of Medical Devices Classification"

@greg-westnine - I have no idea about "which of the conformity assessment elements have been applied... fill me in?

[greg-westnine]

I agree that with the suggestions that OVF is a 'voice synthesizer/digitizer' but I think Risk Class A, rule 12 is referring to FDA rules, not EU. We can quote the assessment in the Device Description that OVF is a Class I device.
I think conformity assessment elements means the evidence you are providing, ie the contents of the technical file.

[greg-westnine]

Updated to be more in line with some examples I reviewed, and also to fill in the checklist more thoroughly.
Declaration of Conformity.docx