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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? ...
The third version of ISO 14971 is currently being published. The new version of ISO 14971 is set for release in Q4 ...
The Special 510(k) program was established to create a more efficient review process (30 days instead of the 90 ...
ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name ...
Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and Radiological ...
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