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Hi everyone.
I'm new in this forum and in this business.
I'm helping a friend of mine that's creating a new electronic medical device(similar to the equipment that reads and registers a patient's heart beat for a single day, class Ia).
I have three questions:
1. What are the main points that a Product Manual Dossier should have to ensure its conformity and CE marking?
2. To ensure that the equipment is in accordance with the IEc 60601-1, is it enough to have it tested in a laboratory that is accredited to do those tests?
3. Could someone give me a site to get the symbols or examples of symbols to go in conformity with EN 980:2008?
Thanks in advance.
Yours truly
Xixi
I'm new in this forum and in this business.
I'm helping a friend of mine that's creating a new electronic medical device(similar to the equipment that reads and registers a patient's heart beat for a single day, class Ia).
I have three questions:
1. What are the main points that a Product Manual Dossier should have to ensure its conformity and CE marking?
2. To ensure that the equipment is in accordance with the IEc 60601-1, is it enough to have it tested in a laboratory that is accredited to do those tests?
3. Could someone give me a site to get the symbols or examples of symbols to go in conformity with EN 980:2008?
Thanks in advance.
Yours truly
Xixi
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