Guest
Guest
Create New Topic As guest or Sign in
Assign topic to the user
-
Necessity of team training in Good Manufacturing Practices
Is it essential to keep the entire team trained in Good Manufacturing Practices?
-
Does your toolkit have any policies or appendices that surround FDA ESG or Digital Certificates?
Does the ISO 13485 Toolkit have any policies or appendices that surround FDA ESG or Digital Certificates? -
Labeling Instruments with calibration information
Hello, I was wondering if you could show me in the ISO regs where/if it states that an instrument needs to be labeled with a sticker stating the day it was calibrated and the next time the calibration is due? -
MDR Medical device documentation for distributors
Firstly I should introduce myself. I am Compliance Officer for *** based in the UK. *** are distributors of medical devices and have a vast range of products acquired from our list of approved suppliers. We, as an organization have been authorized by our suppliers to ensure that all products meet the MDR standards and, to document and submit these products to the *** website. What I need to know firstly, is what documentation I need to put together for each product, such as certificate, instructions for use etc…. We as an organization are already ISO 9001 accredited so do not need to undertake another ISO accreditation. Is there a specific list of documents required for each product? I am taking this is phases, and phase I will be to pull all documentation together. Phase II to establish the class of products and finally Phase III to submit to the website. -
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
My concern is to know what will the requirements be when MDR will go live ( May 2021) in order to conform to ISO 13485 in the sub contractors position ( not the manufacturer but sub elements or services of the actual medical devices, the one, the manufacturer is marking). -
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)?