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  • The bes resource that I always used for correct assignments of CND codes is the following document: https://www.salute.gov.it/imgs/C_17_pagineAree_328_listaFile_itemName_13_file.pdf IVD codes are indicated with “W”. The reagents are more then 100.. The text is in Italian language only. Best regards K --------------------------------- Katarzyna ...

  • Good morning, During this crazy period, I found very good responsiveness in Tuv Sud and SGS. We are 1000 employees company. Beast regards K --------------------------------- Katarzyna Chrusciel Engineer Italy ---------------------------------

  • Good morning, I found this information very useful but for my understanding this deadlines are applicable for legacy medical devices (MDD). For all MDR products, economic operators must register within three months of placing their first (MDR) product on the Swiss market. Importer needs to identify itself on the device, its packaging, or in a "document ...

  • I have read through the pain points discussed on June 11 and am in complete agreement with the ideas expressed by Beth, Liz, Hiral, Richard, Ginger, and anonymous. Permit me to share some of my own experiences.   I have been a regulatory and compliance consultant with additional full-time staff for almost 40 years. Occasionally we even did clinical ...

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  • In addition for SOTA evaluation I will suggest to summarize standards and clinical practice guidelines of the medical field. The MDCG 2020-6 guidance mentioned before provides some more information on state of the art and similar devices: "Evaluation of state of the art, including evaluation of clinical data from similar devices. Data from similar ...

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Volunteer Appreciation 2021

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

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