Our previous attempts at drawing up design control documents were met with criticism from the auditor. Would you be able to email me an example of an approved design control document for ISO13485:2016. We need to improve the format too so a template would be great if you have one. I need help defining the user requirements, inputs, and outputs.
Different standard for sampling?
I recently joined a medical device company that still uses the MIL standard for sampling. Is that acceptable? I am only used to ANSI at this point
Can the preparer be the reviewer and approver for clause 4.2.3?
Per ISO 13485 clause 4.2.3 requirement, shall the document preparer, reviewer and approver are the different people?
Stage 2 audit requirements
We have a Stage 2 audit scheduled for March. The scope of our certification is the control of manufacture as we are intending to outsource all manufacturing. We don't yet have the manufacturers onboard and are arranging Quality Agreements with them now.
Is European certification equal to ISO 13485 ?
I have a question about ISO standard adaptation for the European company.
Establish QMS compliance to ISO 13485 as a reagent manufacturer
We would like to establish QMS compliance to ISO 13485 in anticipation of business with IVD company wherein our reagent would be a part of their IVD kit. (We will not be involved in the manufacturing of any IVD per se) How would clauses which are specific to a medical device like medical device file, advisory notice, risk analysis, complaint handling etc as per ISO 14971 be applicable for us?
Certifying a family of products under ISO13485 when company is ISO 9001 compliant
Hello, Currently we are certified under ISO9001:2015, however in the next months we pretend to certify a family of products under ISO13485.
What else do I need to be ISO 13485 certified when I am ISO 9001 certified?
I am not currently ISO 13485 certified but 9001:2015 certified. What do I need to be also 13485 certified?
ISO 13485 for small companies
It's regarding the standards fit into an organization with only 2 employees. We develop software for medical image management and (as it seems) need to get a 13485 compliant QMS in order to re-register our products according to MDR. The standard seems to be more geared towards larger organizations (talking a lot about management, CEO, CMO etc..)
Reporting of AE to FDA
We currently have a question we are unable to find an answer to. Scenario: A box contains 200 individually wrapped products. Each individually wrapped product seems to have a loose fray that is visible to the customer. Event = "Loose fray on Product A package." One Event, One product, 200 qty. Our question is as follows: Do we report 200 individual reports, or do we report 1 report specifying that 200 products were associated with the event?