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Kevin Randall, ASQ-CQA, BS, RAC

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United States

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1 to 5 of 50+ total
Posted By Kevin Randall 28-Mar-2024 16:43
Found In Egroup: Regulatory Open Forum
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There is definitely no "need" (i.e., European Regulation 2017/745 or /746 legislative requirement) for a CE mark on a medical device manufactured in the EU for distribution in the U.S. CE marking only pertains to devices placed on the market in Europe's Union. Moreover, it is most ideal (and arguably ...
Posted By Kevin Randall 28-Mar-2024 12:39
Found In Egroup: Regulatory Open Forum
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The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological evaluation, radiation sterilization dose, ...
Posted By Kevin Randall 25-Mar-2024 16:29
Found In Egroup: Regulatory Open Forum
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The typical approach is to either Use your established Regulatory Strategy template/process combined with the sufficient expertise in each jurisdiction to prepare and write the Strategy; or Hire an outside expert who can do this for you. We'd be glad to help. ------------------------------ ...
Posted By Kevin Randall 25-Mar-2024 12:51
Found In Egroup: Regulatory Open Forum
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FDA uses "particular" in the colloquial dictionary sense. FDA defines "material" as "the substance or substances of which a thing is made or composed". An example of a particular material is 316L stainless steel. Some other common examples are polypropylene and polyethylene. When identifying a subject ...
Posted By Kevin Randall 22-Mar-2024 12:19
Found In Egroup: Regulatory Open Forum
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Collectively, Part 7 and 806 in total only involve a firm's recall-related correspondence with FDA for two scenarios: Mandatory Part 806 reports for those situations that track as Part 7 Class I and Class II recalls; and Voluntary (as in, not required) Part 7 notification by the firm to FDA for ...