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?
Deviation from requirements for batch identification
I was wondering if you can tell me about the categorization of a finding regarding batch identification
Definition for critical suppliers in the context of ISO 13485
Hi, I am trying to find a definition for a critical part (to determine critical suppliers) in the context of iso 13485.
CE mark and ISO 13485 for medical device in EU
Is it necessary to be ISO 13485:2016 certified before pursuing the CE Marking? Or is having the ISO 13485 more of a benefit, and not a requirement.
Quality objectives or KPI in QMS Manual?
Hi. Just wanna know if the declared procedures in our QMS Manual should always have a Quality Objectives? Or is it just okay to have a KPI for whole department? Thanks a lot.
What are minimum personal/roles for the new company per ISO 13485?
What are minimum personal/roles for the new company per ISO 13485?
Applicable standards to comply
If my company is working on providing services (etc lab imaging services), which standard should we be certified on ? Do we still need ISO 13485?
Product Realization requirements for distribution and manufacturing facility
I am currently doing an ISO 13485 system for the first time. I have several years of experience in ISO 9001 and EHS but need help in 13485 please.
Applicable ISO Standards for Sterilization
Dear Sir, I work as an engineer in a research laboratory for SGS. I am contacting you because we are currently running a project about microwave sterilization. Can you please help me finding a way to have access to all ISO norms about microwave sterilization or sterilization in general? Are they available online?