Regulatory Open Forum

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  • 1.  RA costs

    Posted 05-Oct-2021 10:19
    Hi, Working on the budget for next year I was wondering if anyone would be willing to share any information they might have about what the Regulatory Affairs department costs are as a % of the total company turnover? Either from benchmark research or personal experience...
    Thanks

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    John Gibbs
    Mortsel
    Belgium
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  • 2.  RE: RA costs

    Posted 07-Oct-2021 15:38
    Difficult to answer without knowing what kind of devices you make (US and EU classes differ, different registration pathways, conformity requirements and certificate maintenance needs depending on classification), regions you are interested in marketing (N. America vs EU vs APAC), whether you are OEM or likely to be a distributor only. Additionally, what are the different activities RA is going to be accountable for - QA, Clinical, post market tasks too or do you have dedicated teams for those? Plus the size of the department, titles, remuneration etc. These are some of the things you'll need to factor in.

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    Vidya
    USA
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    Original Message


  • 3.  RE: RA costs

    Posted 08-Oct-2021 02:38
    Hi Vidya, thanks for you reply. I understand there are many variables but I was looking for a ball park range of %. But to make it clearer we are an OEM active globally producing EU class I, IIa, IIb products and the department covers RA, QA and post market. But I understand this is a difficult question to answer.

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    John Gibbs
    Mortsel
    Belgium
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    Original Message


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