QMS

I work for a start-up company, and I developed some SOPs, including the quality manual. We are still in the development stage of developing a medical device , we didn't get the FDA approval yet , so my question is whether we need to have all of the SOPs required by QMS, and whether we need to fully train our employees at this stage, and is there any particular order to follow for the SOPs.

Those are difficult questions to answer in a forum like this so all I can offer is some general responses.

If your target market is the US (only) then you need to be compliant with the QSR (21 CFR 820). That does require that you have a quality management system in place but it does not prescribe when things have to occur. (If you plan to market outside the US, you'll want to get on board with ISO 13485.) Some of the basics like document control and configuration management should be established early just as good business practices.

Employees must be competent to perform the tasks they are assigned and you have to have evidence of why they are competent for those tasks. By and large, this will be through experience (resumes) but there are going to be some things (e.g., risk management) that require special skills.

"Winging it" is not the best plan. You should ensure your regulatory pathway is well defined and then map out how you get there, including establishing and operating under a quality management system. I've seen a number of companies get to the point where they think they can submit for market clearance only to find out they didn't do things per the regulations. You don't want to be there.

Hi Nawal,
For a startup, the order of SOPs should concur with the activities of the company. For example, the complaint handling SOP could be created last, while the design controls SOP first. If an inspector arrives, the expectations are that all the SOP are released and training is current.
All the best,
Quinn

Hi Nawal,

QMS should be in place and in use as a working system well ahead of submitting applications to FDA. Irrespective of receiving the approval FDA would ask for an audit on certain occasions on submitting applications and manufacturers should have a well documented in use QMS in place.

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