Modern medicine and technology have changed healthcare significantly. Medical Devices are constantly being improved upon and created to treat diseases that many people suffer from. However, before a medical device can be available on the market, it has to be compliant with the regulations set forth by the FDA. Here are the reasons medical device compliance is crucial to your medical device success.
Ensure Safety For Patients
Since medical devices are used to treat patients, it has to be proven that it is safe, not detrimental to their health. Patients and medical professionals assume medical devices are safe to use, hence, they require compliance before being on the market.
Medical devices can save lives, but before that, they have to show they are safe to use. Once a medical device has been ensured safe to use, it needs approval from regulatory bodies (the FDA).
Get Approval From Governmental Bodies
There are many regulatory bodies that manufacturers must comply with. In the case of the medical device industry, the largest governing body is the FDA. They emphasized creating quality products that will be in everyone’s interest.
In 2011, the FDA launched the Case For Quality Program to help medical device manufacturers create better products. This is why ISO 13485 focuses on the quality of medical devices.
Getting FDA approval for a medical device is the most crucial step for sharing your device with the country.
Manufacturing in the US requires FDA compliance. For international use, you will need ISO compliance. Many cases, however, require adherence to both regulations. Without meeting approvals, you may face penalties and ultimately, your device may never reach the market.