Regulatory Affairs Specialist, Joel Reid, is here to discuss the best time medical device and drug developers should start building a quality management system, or QMS!
Can't watch right now and would rather read a quick summary? Here's a recap of what Joel shares in the video:
Hello, Joel here from the team at Proxima Clinical Research.
Today we're going to answer a key question for device and drug developers: when should you start a quality management system or QMS? Now, you may be wondering what exactly is a QMS?
Well, a quality management system is a comprehensive set of production related policies, processes and record keeping tools that are put in place to address and prevent issues with your product. It's a critical prerequisite for all regulated sectors in medtech and biotech, ensuring that your product meets the standards outlined in the Code of Federal Regulations, or CFR.
There are numerous benefits to having a QMS. A good QMS provides assurances on regulatory compliance, consistent product quality and audit readiness. It also helps streamline operations, improve efficiencies, reduce errors and mitigate risks associated with product development and manufacturing.
Because of these factors, it's ideal to start a QMS as early as possible in your products development. Implementing a QMS early on allows you to take advantage of its utility from the outset, which can save you time, effort and money in the long run. An early stage QMS is critical to have before encountering any quality concerns or recalls in order to identify and address the main cause and prevent any future occurrences.
With that said, it's never too late to implement a QMS and companies who integrate a QMS in later stages will still have a lot to gain by doing so. If you have any questions about QMS or are looking for a knowledgeable CRO that has experience with building robust quality management systems, reach out to our team at proximacro.com.
If you'd like to get in depth about when or how to implement a QMS, check out this article.