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  • 1.  Employee training QMS

    Posted 08-Jun-2023 09:46

    Hi everyone !

    I have a question about employee training and qualification. As a startup company in the process of developing a medical device, do we need to have every employee fully trained on all SOPs at this stage before getting any FDA approval, and does HR need to keep a copy of the degree and resume at this stage as well?

    Have a fantastic day !

    Nawal Tiouri
    Quality & Regulatory Engineer
    Ypsilanti MI
    United States

  • 2.  RE: Employee training QMS

    Posted 08-Jun-2023 16:08

    First, FDA has (at least) two processes approval and clearance. Be careful to use the correct term for your device. FDA Investigators can be sensitive to the distinction.

    After (and sometimes before) FDA gives the OK on your premarket submission, QSR comes into effect. It requires that you have sufficient personnel with the necessary education, background, training, and experience. For education, background, and experience you need to determine the needs for each employee depending on the job and keep the records to support this. You might require a design engineer to have an engineering degree and five years of experience. The resume usually has that information.  One the other hand a production worker may need a high school diploma and three years of experience in production work. A job application usually has this information.

    HR is a traditional place to keep these records. It means the FDA Investigator will go to HR for the records.

    Dan O'Leary CQA, CQE
    Swanzey NH
    United States

  • 3.  RE: Employee training QMS

    Posted 09-Jun-2023 00:06

    At this stage of development, it is not necessary for every employee to be fully trained on all SOPs before obtaining FDA approval. However, it is essential to establish a QMS that includes employee training and qualification as part of the overall process. This will help ensure that your employees are adequately trained and competent in their respective roles.

    As for HR keeping a copy of the degree and resume, it is a good practice to maintain employee records, including their qualifications and work experience. This can help demonstrate that your company has a competent workforce and is committed to maintaining a high level of quality in the development and manufacturing of medical devices.

    John Zachary
    Orca1 DI

  • 4.  RE: Employee training QMS

    Posted 12-Jun-2023 08:56

    Hi Nawal, 

    Before submitting a 510K/PMA/other you should already have a QMS in place according to 21 CFR 820 (or usually ISO 13485 + a gap analysis of the FDA regs). Having a QMS means that you should have all employees trained in the SOPs relevant to them, and QA or HR should keep evidence of their qualifications and responsibilities. 

    In a practical way, you should have per employee:

    • job description
    • education/experience evidence (university degree, CV, licenses, certificates, etc.)
    • training record/evidence of the relevant SOPs (if you are unsure if a SOP is relevant to someone, err on the safe side).

    Also, your SOP should include how you train employees when SOPs change in a significant way. And those training records should be added to the employee file. Auditors will ask you for a random employee for a random SOP and ask you for the training record to ensure you are training them (to the latest version of the SOP).

    Remember that after you get 510K clearance FDA could conduct an unanounced inspection, including QMS. For PMA I think QMS/inspection is a requirement, but you can check FDA website on that.

    Good luck!


    Daniela Mahan Soler Esq, RAC
    Regulatory Affairs Manager

  • 5.  RE: Employee training QMS

    Posted 13-Jun-2023 04:23

    In addition to Daniela's detailed answer, just a note that the auditor may look for an overlap between a role's JD and actual CV of a person hired for that role, and there should be an overlap. For example, if the JD says the role is looking for someone with a Masters degree, then do ensure the person either has that degree or there is a documented justification for why he/she may not have.

    As for the training, a type of matrix (Excel) may be useful, indicating role (e.g. engineer) vs each SOP, and then you tick which one is relevant. Simple Google search can give you some examples. And yes, records of training (internal/external) are crucial.

    AnaCiric, PhD, RAC-Devices
    RA/QA Specialist

  • 6.  RE: Employee training QMS

    Posted 13-Jun-2023 08:47

    Hi Nawal,

    regarding your question - every employee fully trained on all SOPs - It is advisable to have employees receive training on relevant SOPs that are applicable to their roles and responsibilities. Training should cover topics such as quality management, safety, regulatory compliance, and specific processes related to the development of the medical device. The extent of training required for each employee may vary based on their job functions and involvement in the device development process.

    The FDA does not typically require that every employee be fully trained on all SOPs before obtaining FDA approval for a medical device. However, it is important to have appropriate training processes in place to ensure employees are adequately trained and qualified to perform their assigned tasks related to the device development, manufacturing, quality control, and regulatory compliance.

    It is generally good practice to maintain personnel records that include basic information such as educational qualifications and relevant experience. As your company grows and you move towards regulatory approvals, it becomes increasingly important to maintain comprehensive personnel records which can be done by HR

    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    3470 Superior Court
    Oakville ON L6L0C4