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As a medical device manufacturer, every company must establish a QMS in compliance with 21CFR 820 (if you sell in ...
The process of creating, manufacturing, and marketing a medical device can be extremely difficult to navigate. ...
Making a change to the design or the manufacturing process of your product that is already out in the field? You ...
Clinical Decision Support Software is a tool that is utilized in making decisions for the diagnosis, treatment, ...
Having a regulatory strategy to bring your device to the market may not seem like the most exciting part of ...
A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same ...
If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to ...
The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, ...
Every medical device manufacturer in the US should expect FDA to conduct an inspection at some point, but what ...
When most people hear the term “medical device”, they think of surgical and hospital tools, like stethoscopes or ...
FDA has introduced a new program for medical devices and for device led combination products. Under this program ...
Do you have a low to moderate risk medical device that does not have a substantially equivalent predicate device? ...
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