Quality and Regulatory Consulting | QES Medical

Is my product a medical device?

This is a question all start-ups, as well as existing companies, must answer correctly. I recommend the following FDA's CDRH Learn...

FDA's Biocompatibility Assessment Resource Center

I found this FDA's resource page very interesting and straight to the point. In addition to following these recommendations, I think it...

Risk Management. A Tool or a Curse?

When it comes to implementing and maintaining risk management for medical devices, you likely face the same challenges as many companies....

Be Proactive, Not Reactive!

When looking at the cycle of maintaining your Quality Management System (QMS), you face the same challenge as many companies. You go...

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