Safety and Effectiveness of Medical Device - What evidence needed?

Timothy1

Involved In Discussions
#1
In a recent audit, the auditor asked for objective evidence for safety and effectiveness of each of the medical device manufactured by us. Appreciate if you can let me know what evidence typically shown for this. We make ultrasound gel.
Thanks in advance
Tim
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Hi,

ISO 13485:2003 doesn't relate to device effectiveness at all. It relates to device safety, but only indirectly, by requiring that device safety requirements are included in the design input (which is later expected to be addressed in the design output, which should be verified... and so on). I think asking the auditor what is the basis of this requirement (assuming this is a strict-ISO-13485 audit) would not be inappropriate.

In the USA, a cleared 510(k) or PMA could serve as evidence that the device's safety and effectiveness are adequate, by FDA's standards, given of course that the device is not exempt. In the EC (and other similar systems) it might come down to a compliant clinical evaluation, as prescribed by the MDD and elaborated in guidance documents.

Cheers,
Ronen.
 

yodon

Staff member
Super Moderator
#4
ISO 13485:2003 doesn't relate to device effectiveness at all.
Might want to take (some) exception to that. Under Validation (7.3.6), the standard says:

Design and development validation shall be performed ... to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. (bold type for emphasis)

To me, that speaks directly to efficacy. So circling back to the OP's question, I would suggest that the validation can be used (at least in part) to support effectiveness (which, as you indicate, may well be a clinical study).

Further, if risk mitigations were identified and verified, that verification would be evidence of safety.

Timothy1: audit finding aside, how does your company know the gel is safe and effective?
 
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