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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? -
Requirement of ISO 13485
We are currently developing self-scanning application for a Thermal IR camera to help diagnose early-stage cancer as well as Pet care, with the help of AI.
I have a basic question here regarding ISO 13485, whether we will require this standard for our application or Not?The concern has arisen as this application will give only indication/guidance to the user to go further to visit a doctor if there are any abnormalities/outliers using AI.
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IS ISO 13485:2016 latest version?
Would you say, ISO 13485:2016 is this latest version, isn't it? Exclusion clauses are 6,7,& 8?
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ISO 13485 implementation
1. The first thing I would do myself is to implement a general procedure to keep track of actions and agreements within the organization. I do not see it? Why? How to do it?
2. We are a very small startup for a simple small noninvasive medical device. Both my partner and myself are very experienced in MRI (***), CT (***), etc, although it is 20 years since we worked in a QMS. I want to define Research and predevelopment as a process outside the QMS, then Design transfer to a clinical trial process and to subcontractors inside the QMS We will subcontract engineering/development, manufacturing, service, logistics to ISO13485 certified high-quality partners. We will have these partners audited regularly by consultants we contract and sign the audit reports ourselves after review. Can we somewhere buy a core (just enough) QMS that complies with ISO13485? Your toolkit is much more than we need, do you have a core toolkit as well?
3. Do you have a service that adapts your toolkit to our needs? Including filling in of company name etc.
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Affixing ISO 13485 mark on product
If I am certified with ISO 13485. Is it applicable to put ISO 13485 mark or slogan on my medical device product? And what is the reference of your answer if it is yes or no?
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ISO 13485 Documentation & implementation
I want to ask that ,is ISO all documentation is same for disposable medical device & IVD or any change in IVD ?
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IVD Medical Devices for Infectious Diseases
1. For IVD Medical Devices for Infectious Diseases e.g. Covid-19 are these classified in IVDR as high-risk Class D?
2. And must the CE Mark have the NB 4 digit Number next to the CE Mark?
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Cross-mapping ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards
I am trying to cross map ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards that apply to medical testing labs that develop IVTs. In development of a QMS that will satisfy all of them. Any advice? -
UDI procedure that covers the EU MDR requerment
Hi Do you have UDI procedure which covers the EU MDR requerment.