Required by the regulations for most medical devices, a Quality Management System is first and foremost one of the most powerful tools in a medtech startup arsenal.
But powerful does not mean easy. There are countless possible ways to make an inefficient QMS that drag things down - rather than supporting smooth processes.
The good news is that a QMS is not meant to be in a frozen state. It is meant to evolve. And this evolution can start early, simply and without pain.
If you are an early stage entrepreneur, you may not want yet to commit to a full QMS that comply with ISO13485 or any other standard. You are not ready to engage a notified body. There are other priorities indeed. Nonetheless, we believe the earlier you start this journey, the easier it will be. Understanding the principles of Quality Management, practically, now, whilst you are in the early stages in the development of your innovation, is the best opportunity you have to build a culture of Quality deep in your organisation’s DNA.
We can mentor you in this exercise so when the time comes to go the Full Monty, you will be in confident control of the process.
If you are an established manufacturer, or are getting close from becoming one, and have already implemented a functional QMS, you know already that it needs to be periodically audited and reviewed as part of your own processes (internal audit - not a notified body or regulatory agency audit)). And that this must be done by an auditor independent from the processes audited. We can help you with that as well. Call us :)