J
jennaleeb
Hiya! Thanks to everyone who provides such valuable insight in this forum.
We are a small medical device company (1 product, 4 employees) and manufactures a device that is Class I sterile in the EU and Class II in Canada. We outsource all manufacturing processes to another ISO certified company.
We are in the process of setting up our quality management system and it has come to my attention that CAN/CSA-ISO 13485 permits manufacturers of Class II medical devices to exclude clause 7.3 - Design and development from the QMS, with justification(s), and Annex V of the MDD requires only production quality assurance system.
What does "justification" mean? Does anyone have an example? I assume "is not required by markets the product is sold in" is not good enough.
Thanks!
We are a small medical device company (1 product, 4 employees) and manufactures a device that is Class I sterile in the EU and Class II in Canada. We outsource all manufacturing processes to another ISO certified company.
We are in the process of setting up our quality management system and it has come to my attention that CAN/CSA-ISO 13485 permits manufacturers of Class II medical devices to exclude clause 7.3 - Design and development from the QMS, with justification(s), and Annex V of the MDD requires only production quality assurance system.
What does "justification" mean? Does anyone have an example? I assume "is not required by markets the product is sold in" is not good enough.
Thanks!