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1. We are trying to determine which documents in your 'ISO 13485 & MDR Integrated Documentation Toolkit' are required for a 'distribution company' distributing medical devices. Understanding this more clearly will help to us to secure funding to purchase.
2. For use of this pack for a 'distribution company', can you please update your 'ISO 13485 & MDR Integrated Documentation Toolkit' document with an additional column indicating which procedures would be needed. This will help to convince management on the necessity to purchase the pack"
Hello, I was wondering if you have workflows and electronic signatures for the 13485 module and if they are 21 CFR 11 compliant.
what kind of insurance is that?
which insurance companies are available for that?
What are the guidelines for bar codes on single use, sterile medical products under this new MDR?
We are into manufacturing of medical devices, is it necessary/mandatory to audit vendors which are critical?
Can an HDS be done between countries?
I mean can we store medical data in a country and use the date in another country?
Are the procedure numbers cross-linked in the documents-kit? For example, the product validation document will refer to several documents, e.g. product development plan, risk management, verification & validation procedures, etc. Do all these procedures have numbers/codes already implemented and cross-referenced or do I have to do the work?
I have a question about IVD
if I have an in vitro diagnostic device intended for professional use not listed in annex II of IVDD 98/79/EC
and I want to sell the product in other countries instead of EU but these countries require that the product to be CE mark (customer in XYZ for example)
can I issue the self-declaration and put CE on the product without authorized representative?