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ISO 13485:2016, Clause 4.2.3 Medical Device File

#1
Can a contract manufacturing company exclude clause 4.2.3 (a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use? Understand that ISO standard requirement is you can exclude any clause under 7 only. However, as a contract manufacturer, we are not able to provide these information for clause 4.2.3(a). Anyone can help, the certification body gave nonconformity because of not able to provide any evidence for 4.2.3 (a).
 

James

Involved In Discussions
#2
Hi Karen

To my mind its inconceivable that you could exclude any part of 4.2.3

Giving more information about what you do and why you think excluding the clause is appropriate may help others to comment
 
#3
Hi Karen

To my mind its inconceivable that you could exclude any part of 4.2.3

Giving more information about what you do and why you think excluding the clause is appropriate may help others to comment
Understand that cannot be excluded, however as a contract manufacturer, we are not able to provide those information stated in the standard.
 
#4
4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain the responsibility of conformity to this International Standard and to the customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements.

If the brand name is registered under your company the entire product is your obligation and regulatory authorities will definitely see your contracts and labels, device file, i might suggest you kindly include this and take a wavier for some parts of 7.3 Design and development
 

yodon

Staff member
Super Moderator
#5
As the CM, you may not be responsible for the complete File but you clearly contribute to these items:

c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;
d) procedures for measuring and monitoring;


As others have stated, it's unlikely you can make the entire clause NA but you do need to describe what you do for these items (and how you coordinate with your clients on this and the other materials).
 
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