Neutral Electrode IEC 60601-2-1 Test House

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Xsailor

Registered
Hi,

Last year, the company I work for, acquired a manufacturer of Electro surgery Neutral Electrodes (Class IIb as per MDD).
The product certification was done by BSI and Test reports were from a SGS lab in the US.
We shifted the manufacturing site to India and were granted the 13485 certificate for the manufacturing site by BSI – however, it has been over 7 months that I have been struggling with the review of the technical file (TF) and the queries of the reviewer (It is a peer review) keep getting more an dmore complicated and … annoying!
That would be another thread!
Could someone guide me to a test lab which would undertake such a test? And perhaps also, another NB who would be happy to help with the CE certificate – I have learned that BSI has no auditor/assessor/reviewer with hands-on product knowledge and this is leading to delays which I am finding very difficult to justify.

Thanks in advance.


PS: Disclosure – I am responsible for overall management and am not the QA manager, who too is new and rather ill aware of the such devices.
 
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