Design and development validation of ISO 13485
Design and development validation of ISO 13485
Clause 7.3.6
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.
Advertisement
Sponsor sites:
1. Phrases For Performance Appraisals.
2. Interview questions and answers.
This entry was posted
on Sunday, November 22nd, 2009 at 10:15 am and is filed under ISO 13485 standard.
You can leave a response, or trackback from your own site.
