Most companies that form with the intention to create a regulated device or decide to pivot to a regulated device realize that sooner or later, a quality system really is necessary. The common path takes them to a consultant or a new hire who will wave the magic wand and they will have a quality system worthy of the FDA or other regulators. Once they pay the hefty prices and get their quality system set up, it’s time to place it on a high shelf, check the box, and forget about it until they need to retrieve it for the audits.
Well, that was a nice scenario but now that the dream is over, let’s discuss what the reality should be. A quality system and the supporting paperwork is not just a check in the box to satisfy the authorities. In fact, the quality system paperwork is just a documentation of the culture of a company to show that they understand how to ideate, design, manufacture, and keep track of their products in a way that can be safe and effective.
Sure, you probably make safe products, but how would you hire a new employee and show them the ropes without having to spend hours and hours downloading all your best practices? How would they know how to design with the constraints they must observe? These all need a place to be housed so everyone working in the company is aware of the best practices, in this case dictated by the regulatory body more than the company’s preference.
If you are a software only company, don’t think this doesn’t apply to you. In fact, the lean or agile systems of code, debug, launch then observe is the opposite of what a regulated medical device should do.
A quality culture dictates the mindset to outline what you intend to do before you set out to design. What do you want to make and what are the critical features of the final product? Once you determine it, what are some of the risks associated with each item, what can go wrong? When small or big issues arise, how do you plan to prevent that from happening? All of this is probably very familiar to an engineer, but creating documents to support these is not the dream of an engineer when they are looking to start their career. A well-structured system makes the pain points disappear, so engineers can contribute to a quality system fast -that is the golden ticket.