ISO 13485 & EU MDR - Expert Advice Community

Requirement of ISO 13485 for manufacturing of semi-finished product

I wanted to ask that if a company manufactures a semi-finished product ie. braided cords of polyester/silk/ UHMWPE ( ultra-high molecular weight polyethylene) materials do you need an ISO license or you can make a QMS according to ISO-13485 and get it certified? Also what all documents required for it?

ISO 13485 requirements for outsourced processes under MDR

Incorporation of conformity assessment in QMS

I have been asked how conformity assessment can be incorporated in QMS?
Could you help me with this, please?

Minimum time frame to implement ISO 13485 to Stage 1

HI, If we purchase the ISO 13485 toolkit, and apply a great deal of effort, what would be the most aggressive timeline to apply for certification - in your expert opinion. We are in ***

Procedure for clinical trials

I am looking through the kit and I have not been able to find a procedure for clinical trials

Software validation procedure

We manufacture nursing beds intended to use in rehabilitation facilities and home care, only electric and electronic components are drive units (lifting actuators and control boxes) which we supply from the world-leader in that area. We do not change anything at all. So do we have to do anything with Software validation procedure – is it apply to products or to the software used in an organization (I mean computers, ERP software, CAD programs)?

ISO 13485 certification for suppliers

Document coding system

We recently started with the use of your toolkit to implement ISO13485.
I would like to get some advise about the use of document codes.
Procedures are suggested to be PR-XX
Record: PR-XX-Y (with XX the same as the corresponding procedure)
But how would you differentiate: forms, sheets, workinstructions, reports,...
In a previous company I used to work with SOP (standard operating procedures), WI (for workinstructions) , FORM (for forms and sheets), REP (for reports). This was ISO 15189.

Can you advise what could be a good document coding system for the different records?

SOP related to IFU

In the toolkit was not included any SOP related to the control of labels and IFU’s of medical devices.

As it is obvious to us that we need such an SOP, could you provide me with a template of the procedure and the relative form?

ISO 13485 nonconformity

I wonder if you can answer a question for me.  My company is a custom manufacturing company that does not make its own product.  We help our customers in the design of their product and also build product for them.  We are ISO 9001 & 13485 certified. 

We have no change agreements in place with many of our medical device customers that clearly state if there is a change to process, documentation, components, tooling/equipment, etc. …we are required to notify them to (depending on the customer) make them aware or gain approval.  We also have medical customers where there is no such agreement.  One of these companies was recently purchased by a larger medical device company who provided notice that within a number of months, my company will be under a no change agreement, which we signed but is not applicable until July 2020. 

A supplier audit was conducted by this larger medical device company at my company’s site this past March, in the audit results there is a finding for an internal change order that did not effect form, fit or function of the assembly and keeping in mind there is not a “no change agreement,” yet the auditor considered this a noncompliance. 

I have perused ISO 1385:2016 and cannot find anything that would support this finding.  All of our procedures are in accordance with both 9001 & 13485.  Would you consider this a finding and if so, can you explain why?  I’m only looking to understand the perspective of the finding where there is not a “no change agreement” and we did not change material and the change did not affect form, fit or function of the assembly.