Today in my company we have dissussed about this question that I have never raised myself, the question is if our producs (electronical medical devices class I and IIa under MDD 93/42/EEC) needs that the tests according to EN 60601-1 and EN 60601-1-1 must be performed by an external laboratory accredited or not.
I always have used accredited laboratories to performing these standards and justify the safety and EMC of the medical devices.
But, my new company, if it's a class I, it 's used a not accredited external lab, and if it's a class IIa, it's used an accredited external lab.
And a third option, today has been raised: don't use an external lab for class I products, for example points about labelling, user manual...
And I didn't know reply this question, I know that manufactures use accredited external lab beacuse it's easier to justify the conformity of the products, but how can I justify safety standard without an external laboratory? Thanks a lot for your help
I always have used accredited laboratories to performing these standards and justify the safety and EMC of the medical devices.
But, my new company, if it's a class I, it 's used a not accredited external lab, and if it's a class IIa, it's used an accredited external lab.
And a third option, today has been raised: don't use an external lab for class I products, for example points about labelling, user manual...
And I didn't know reply this question, I know that manufactures use accredited external lab beacuse it's easier to justify the conformity of the products, but how can I justify safety standard without an external laboratory? Thanks a lot for your help