ISO13485 - 7.3.6 Design and development validation

From knowledgebase
Revision as of 09:46, 25 August 2020 by Dirkjan (talk | contribs) (Created page with "7.3.6 Design and development validation Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting...")
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to navigation Jump to search

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Validation shall be completed prior to the delivery or implementation of the product (see Note 1).

Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

As part of design and development validation, the organization shall perform clinical evaluations and/or evaluation of performance of the medical device, as required by national or regional regulations (see Note 2).

NOTE 1 If a medical device can only be validated following assembly and installation at point of use, delivery is not considered to be complete until the product has been formally transferred to the customer.

NOTE 2 Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not considered to be delivery.

Retrieved from "https://wiki.dirkjanswagerman.nl/index.php?title=ISO13485_-_7.3.6_Design_and_development_validation&oldid=3245"