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Steps for obtaining CE certification or CE Mark
WE are a manufacturer of Medical Device Face mask and PPE. We are recently certified ISO 13485 and would like to get CE certification or CE Mark
What're the steps shall we follow?
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Requirement for ISO 13485 of procedure of Human resources and another procedure of Infrastructure and working environment
1. Hi, if we have few employees (8) with many outsourced freelancers, and we don't own the working place, is it required for ISO13485 a procedure of Human resources and another procedure of Infrastructure and working environment?
2. If it is, why?
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Difference between list of internal documents and list of type of records
Looking at the first folder “00”, what is the difference between list of internal documents and list of type of records? -
Are flowcharts mandatory for every process?
Is it a must to have flowcharts for every single process?
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Managing ISO 9001 for Medical Device Distributors who are not manufacturers
How to manage ISO 9001 for Medical Device Distributors who are not manufacturers.
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Why would a non-medical dev manufacturer want to implement QMS using 13485?
Hi, I’m looking for some guidance with quality manual and quality policy, can you help?
ISO 13485 is for medical device manufacturers- why would a non-medical dev manufacturer want to implement QMS using 13485? -
Class IIa product
We are looking to expand our activity in *** as a gate to *** countries and the EU.
Our solution is a support information system for physicians helping them in better identification and treatment of respiratory infectious diseases.
We would like to know what it takes for ISO approval as part of the CE submission in time and money? -
Following same model by the health authorities or by ISO standards
We are an aligner/invisible braces manufacturing company having our head office in *** and manufacturing unit in ***. We would like to expand our business to *** and *** where we would like to sell our products directly to consumers as explained below:
1- A patient will order impression kit and take his/her impression by his/herself and send it back to the company
2-Company then prepares a treatment plan with the help of dentists and orthodontists and send the plan back to the patient for approval.
3- After approval, company will manufacture aligners and send it to the patient.The whole process is monitored by dentists/orthodontists.
The same model is being implemented in many countries worldwide, a few examples are ***, ***, ***, etc.
Our question is that are we legally allowed to follow the same model in *** and *** by the health authorities or by ISO standards.
Thank you!
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Information on product and packaging labels
The label information covers only UDI, but there is no information on product and packaging labels. The product label just does not contain UDI information, UDI is one element of the packaging label. What other information is mandatory for product and packaging label for e.g. the label will have manufacturer address, date of manufacturer, symbols including serial number, etc. I am expecting a procedure for labeling which also includes what information an user manual should have for both end-users and professional users etc. -
Is 13485 Mandatory for making IR Thermometer?
We are entering the market of medical devices - To start with IR Thermometer.
1. Is 13485 Mandatory or ISO 9001 With the scope covering IR Thermometer enough?
2. Is 13485 Certification mandatory to obtain the CE Mark?