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Hi there. I have a question regarding your template for ISO 13485 & MDR documentation. We are an artificial intelligence medical software company that have to CE certify our first product. I read that - as a SaMD company - you also need to conform IEC 62304. Is this included in the toolkit Advisera offers?
"what are the consequences of a medical device company not following regulations?
Does the pack include one and I just can't find it? Or is that something you provide separately or at all?
We are going to will start production of menstural tampons. This type of products are not medical device in EU and are clasified as medical device in USA and Canada. We are located in EU, but our target markets are EU and USA.
Please advise if our manufacturing plant should be certified acc. ISO 13485 ?
Thank you in advance
Hi. With ISO13485 is 'Complaints' only related to product? Customer complaints about service, late deliveries, wrong billing etc. Are they considered Complaints or Feedback?
How to prepare the site for a first-time audit for ISO 13485?
I am specifically looking for a comparison from ISO13485 to EU MDR. Meaning e.g. 13485 clause 8.2.1 references (equal to) to MRD Article 83.
Can a medical device do self-calibration or does it need another calibrating device to do the calibration?
hi, Kristina what services are you providing for the new regulations and Med device RP requirements post Brexit for imported Medical Devices? thanks
Does this ISO 13485 apply to clinical CRO?
We will be in charge of phase II study on an MD and the sponsor requests the knowledge we have on this standard.