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Key elements to know for medical device claims

Medical devices should assist individuals through the healing process or help to sustain their lives after traumatic experiences. Unfortunately, when dealing with defective medical devices, they may cause more harm than good.

Thankfully, people may be able to seek retribution through a claim. There are a few key elements to know in regard to the medical device claim process.


As with any manufactured product, there are certain stipulations that developers and manufacturers must follow. The FDA provides medical device safety information to aid those creators in their process. When manufacturers are in direct violation of the regulations, it is easy to prove a case. Also, in cases where manufacturers develop products by the book and still develop faulty products, it may still be possible to file a successful suit. To aid in deciphering the viability of a case, it may be helpful to speak with a knowledgeable attorney.


Proper classification is critical to the success of a claim. In some situations, a case may look like a medical device claim at first sight, but may actually be a medical malpractice claim. A medical device claim involves a defect in the design or manufacturing of the product, or the improper warning for risks or side effects of use. On the other hand, a medical malpractice claim may arise from the improper installation, placement or use of a medical device.

Statute of limitations

There is a set time limit on when people are able to file injury claims. This time begins when the injury first occurs. Considering that issues due to a medical device may take time to surface, many states employ the discovery rule, which essentially starts the time frame from when a party should be reasonably aware of the injury.

These are a few of the key elements of a medical device claim, however, there are additional factors to consider. It is important to review the relevant laws and regulations to determine the best option.

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