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Controlling Website Content
I recall that the website is considered a controlled document. Is it necessary to control the entire site, or just certain pages? I'm not exactly sure what QMS processes would apply, and if this needs its own SOP (or if it can be tacked on to another). Any advice would be greatly appreciated. Thank you!
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Preparing the documentation
I have limited experience in ISO 13485 and I am trying to get the documentation ready for certification. I don't know where to go. I am doing most of the documents by myself and I am overwhelmed. Is there something that can help me figure out what documents align to what clause IE New product Inspections? What procedures and records I need to create and how to figure out what I am missing.
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Training Validation
I'm attempting to devise a way to validate training, and am wondering if I need to do something for each SOP, or if I can simply create different versions of quizzes for a group of SOPs, and test on a quarterly or monthly basis. Any ideas would certainly help. Thank you!
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Defining and documenting authorities
I need to define and document authorities in regards to yes/no and accept/reject scenarios. My plan is to create an organizational chart, and also to update all job descriptions to include their immediate supervisor. Is that adequate, or do I need to create a flowchart for each process, showing who has authority at each stage?
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Need for meeting requirements per FDA 21 CFR
Our Company will NOT be making medical devices. Company will be making components for the medical industry (Lighting Lenses, Handles, Covers) - Will we need to meet requirements per FDA 21 CFR?
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CE marking
My question is about why companies are allowed to market/sell products before receiving a CE mark approval. In articles I have read it seems that CE marking is a requirement for selling medical devices in Europe however I am looking at a couple of companies that are selling without a CE mark, what is the reason for this? Also if companies do not need a CE mark approval then what is the benefit of going through the process of getting one?
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Requirements for medical device implant
iso 13485 requirements medical device implant
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IVD Smartphone glucometers
Hope you are doing safe, recently I joined an IVD startup manufacturing company, the product is Smartphone glucometers there is no predicate device in the market, now we are planning for ISO 13485, could you suggest to me what strategy should be followed for implementation & technical documentation.
Thanks.