J
Jeffers
Hello Elsmar,
As regulatory manager for a very small medical device manufacturer, I am often in a position where I need to educate myself on standards. We are a CE certified company, and are planning to release a new medical device into the market. The device is battery powered, and is our first "electrically powered" medical device. The device is extremely simple, no complex wiring, no complex circuitry. We have generally completed the R&D stages for the product, and are preparing a 510K submission to the FDA.
I believe our device will need to comply with the following standards:
IEC 60601-1
IEC 60601-1-2
IEC 80601-2-60:2012
I have received quotes from a few different testing houses to perform the required tests and provide a report with the results. It was recommended to me to allow one testing house to perform 60601-1 and another testing house to perform 60601-1-2.
When a company has this testing performed, does a single test house typically perform all of the testing, or is this a frequent relationship, with each testing house specializing in a certain group of tests?
If any other information is required, please let me know. If anyone has a recommendation for a testing house, that is also appreciated.
As regulatory manager for a very small medical device manufacturer, I am often in a position where I need to educate myself on standards. We are a CE certified company, and are planning to release a new medical device into the market. The device is battery powered, and is our first "electrically powered" medical device. The device is extremely simple, no complex wiring, no complex circuitry. We have generally completed the R&D stages for the product, and are preparing a 510K submission to the FDA.
I believe our device will need to comply with the following standards:
IEC 60601-1
IEC 60601-1-2
IEC 80601-2-60:2012
I have received quotes from a few different testing houses to perform the required tests and provide a report with the results. It was recommended to me to allow one testing house to perform 60601-1 and another testing house to perform 60601-1-2.
When a company has this testing performed, does a single test house typically perform all of the testing, or is this a frequent relationship, with each testing house specializing in a certain group of tests?
If any other information is required, please let me know. If anyone has a recommendation for a testing house, that is also appreciated.