Get 4 FREE months of Conformio to implement ISO 27001
Guest
Guest
Create New Topic As guest or Sign in
Assign topic to the user
-
Monitoring and Measurement / Environmental Controls
I was hoping that you could clarify something for me that I am struggling to find information on.
We have been completed 200 surface samples, all but 1 have been within our established criteria. If I select critical areas, can I only test those specific areas ? -
Gaining best skills as auditor
what technique will make a new auditor to gain the best skills with limited resources?
-
MDR Accessories
Please could you provide advise on the following situation: If a part of a medical device is attached to the device, it becomes a component, but if the same part is provided separately to the user in order to fulfil the medical device`s intended purpose, it becomes an accessory. Is that correct? Considering the scope and requirements of the MDR, the components are a part of the medical device itself which goes through the certification process. If the components are manufactured in bulk, kept in stock, and attached to the final product to fulfil the orders requirements, is it required for them to have the date of manufacture on them, or would the date of manufacture provided on the medical device itself would suffice? How about the accessories? Do they need to go through the same process as the medical device itself (e.g. have clinical evaluation, technical documentation, DoC, UDI, labelling in compliance with the MDR, PMS, etc.)? If in order to fulfil an order they are supplied separately and additionally to the medical device itself - in a separate bag, would the accessories need to have their CE mark, date of manufacture, and/or serial number on their label in order to be compliant, or is this not a requirement? -
Why ISO 13485 didn't implement changes and format of ISO 9001:2015 edition?
Why did ISO 13485 not remain in line with the ISO 9001 standard and did not implement the changes and the format of the 9001:2015 edition?
-
Implementation questions
1. How does one determine an organization has enough employees to do the work?
What sort of things need to be looked at, to ensure a company is adequately staffed?2. What sort of things can we do to determine training effectiveness? At the initial training we can have an on the job training or when someone observes you and signs you off on a particular task, but after
What are some industry standard practices.3. Also if my company has an Asset Management, Gowning SOP, Environmental Monitoring and Pest Control procedure that cover the different points in your toolkit example for the infrastructure and work environment procedure will that be good enough or does the information need to live in one document titled “Infrastructure and Work Environment?”
-
Does Medicine Product Class 1 need Certificate from Notified bodies according to ISO 13485?
I attended the Webinar “Overview of steps needed to comply with EU MDR”
Who needs to get certified: included Manufacturer of Class 1 medical devices. What do you mean by certifying? Does it mean to get certified by ISO 13485:2016?
To be honest I have studied the complete EU MDR. By attending your Seminars and Q/A sessions. I understand the Medicine Product Class 1 does not need the Certificate from Notified bodies according to ISO 13485.
We just need to prepare our QMS according to ISO 13485 and EU MDR.
If I am understanding it wrong please guide me accordingly.
-
Would medical face mask necessarily need UV radiation sterilization?
Just curious would a medical face mask necessarily need UV radiation sterilization? Currently I am planning to certify under ISO 13485 in order to supply medical face mask to hospital and healthcare center. Thank you!
-
ISO 13485 requirements for virtual IVD manufacturer
Hi there, I will like some advice on the ISO13485 requirements for a virtual IVD manufacturer which only designs the device?
-
Issues from MDD to MDR in terms of mainly clinical evaluation and investigation
Issues from MDD to MDR in terms of mainly clinical evaluation and investigation, classification, etc.