Clause 7.6 for design and development

[Fadila19821982]

Whether it's a medical device isn't as important as 1) the risk of it not operating properly and 2) whether it is being used as designed.

Can it be calibrated?

Yes, sometimes calibration is executable on the device itself. How can I verfiy the accuracy? Especially when our notified body is asking to follow the ISO 17025 or at least to do the calibration work with a supllier which is ISO 17025 accredited.

 

[Ed Panek]

Contact the OEM Technical support teams