Guest
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?
We have a query regarding SOFTWARE VALIDATION In ISO 13485:2016, Is it mandatory to have validation?
Software vendor is not willing to provide us certificate
As a supplier of reagents to a prospective medical device company, How would medical device file, advisory notice, risk analysis as per ISO 14971 be applicable for us?
How different or beneficial is this as compared to CEN/TR 17223?
State of validation of your templates, especially related to the new 14971:2019. Were already confirmed by notifying body, if yes - which one? I wonder if your consultants can cover risk discussion from a particular device, related to the particular risks affected by this new standard.
My Query is that we don't have DQ/IQ/OQ records for most equipments since they were purchased long before we made this process. Can we make DQ/IQ/OQ records as on today?
Can you please advise what does a face mask with CE 0197 and ISO 13485 carries what correspondent to what BFC etc?