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If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 ...
Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer ...
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be ...
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 ...
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