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"A process that an organization needs for its quality management system and which the organization chooses to have performed by an external party". This includes processes for management activities, provision of resources, product realization and measurement, analysis and improvement.

If you’re launching a medical device startup, you’re probably focused on innovation, design, and bringing your product to market. But there’s one key ingredient that could make or break your success - quality management. You might be thinking, “Isn’t that just for big companies?” The truth is, whether you're a small team or a growing company, establishing a Quality Management System (QMS) is essential for long-term success. Let’s break down why a QMS isn’t just a box to check—it's a vital part of your roadmap to safety, compliance, and customer satisfaction.

A common question we receive from clients is: When is the right time to start documenting for a medical device project, and what documentation should we begin with? For those experienced in regulatory and quality processes, the answer is clear: documentation should begin as early as possible in the project lifecycle. Here’s why early documentation is critical, and how companies, especially young start-ups, can approach it effectively.