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
rdevanathan@tpireg.com3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------
Original Message:
Sent: 08-Jun-2023 09:45
From: Nawal Tiouri
Subject: Employee training QMS
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
------------------------------