Design Validation
Dr Klinisch research provides support in design validation as per ISO 13485: 2016, Clause 7.3.7 and Product standard requirements.
Design and development validation shall be performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
The organization shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.
Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded.
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. A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer.
If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), validation shall include confirmation that the requirements for the specified application or intended use have been met when so connected or interfaced.
Validation shall be completed prior to release for use of the product to the customer.
Records of the results and conclusion of validation and necessary actions shall be maintained.