Hi,
I need some clarity in Clause 7.3.7- Design and Development Validation.
This clause briefs, "As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements".
Is clinical evaluation, a QMS requirement? Does this mean QMS auditors will also look for Clinical Evaluation Report even though there is no product certification?
Kindly clarify this.
Thanks in Advance.
I need some clarity in Clause 7.3.7- Design and Development Validation.
This clause briefs, "As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements".
Is clinical evaluation, a QMS requirement? Does this mean QMS auditors will also look for Clinical Evaluation Report even though there is no product certification?
Kindly clarify this.
Thanks in Advance.