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Computerised systems used to develope and to manufacture MD and IVD



  • Ruth Lopez Magdaleno
    23/02/2021 21:14
    I would like to know if there is any regulated requirement to have fully validated the computerised systems used for the development or/and manufacture of MD and IVD. My question is related to the electronic tools used to manage the MD / IVD not for the MD / IVD itself. Thank you in advance.
  • Dominique Chesnais
    02/03/2021 07:44
    In 21 CFR 820 QUALITY SYSTEM REGULATION related to medical devices, please refer to subpart G - Production and Process Controls, section (i) Automated processes, which states: “When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.” For Europe, you should refer to ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes, section 7.6 Control of monitoring and measuring equipment
  • Ruth López Magdaleno
    02/03/2021 15:42
    Dominique, many thanks for the useful information!!
  • asleypatricia
    31/03/2021 14:25
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