The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard ...
Hi William, Our findings will be published in Therapeutic Innovation & Regulatory Science . I'll follow up when this is published. ...
Hi Sushma, Is your product already placed on the market in Israel ? or do you plan to register a new product? The guidance ...
Thank you Ed. What about updates to the risk analysis made after all the design control documents are complete (for example, due ...
This message was posted by a user wishing to remain anonymous If multiple labs are conducting the same CTA testing for a global ...
I was about to reply but saw that Peter covered pretty much what I was going to say.... outputs of risk management are an input ...
Thank you both. These tips are helpful. BR ------------------------------ Noa Ofer Senior Director QA & RA Microbot Medical ...
Hi If you intend to make significant changes to the manufacturing process for a cell-based product then I would advise that ...
Supporting Ronald's post further: Article 11(3)(a) specifically states that the EC Auth Rep needs to "verify" the EU DoC and File. ...
Article 11(3)(b) requires the manufacturer to mandate the EC REP to keep available a copy of the declaration of conformity. This ...
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