3 Tips for Quality Management System Setup in a Medtech Startup
When engaging with projects related to medical devices, operations are executed based on ISO 13485—a quality management system (QMS) certificate. All medical device companies must acquire the certificate at some point.
I vividly recall the day when I was tasked to set up the QMS for a MedTech startup. Like many millennials, I turned on my laptop and—you guessed it—started to google. Needless to say, the team went through a steep learning curve to secure the certificate.
In this article, I want to share the design philosophy that I found useful when setting up a QMS for a MedTech startup.
What is the International Standard Organization (ISO)?
A committee of experts within the International Standard Organization (ISO) reviews industry best practices and develops a set of procedures that meet regulatory requirements.1
These standards are written in the form of quality manuals such as ISO 13485 (for the development of medical devices), ISO 14971 (for risk assessment) and ISO 9001 (for general quality management systems). Companies then design and implement standard operating procedures based on the manual.
Once ready, the company engages with a third party to acquire ISO certification—which is a prerequisite for regulatory submission, but does not guarantee regulatory approval of your product.
The Lean Mentality
A MedTech startup poses a
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