The medical equipment industry is constantly evolving, so effective oversight is needed to maintain standards.In order to ensure that medical device companies produce safe, high quality equipment for sale in the US, the FDA has put strict regulations in place. But what does compliance mean for medical equipment.
In order to get their medical devices to market, medical device manufacturers must obtain approval from the FDA. This means that companies have to prove that the products are safe and effective.
What Does Compliance Mean for Medical Equipment?
Ensuring that medical equipment is compliant with medical device laws,is one way of safeguarding patient safety. The FDA has stringent guidelines relating to the safety and performance of medical equipment. ThereforeFDA approval indicates that the device has been put through the strictest testing, and has met the requisite standards. As a result,customers can presume that the equipment will perform as expected under all conditions.
Compliance also means that the medical equipment was manufactured in accordance with FDA guidelines. FDA only approves products that are safe and fit, and do what they claim. The FDA also verifies the integrity of the manufacturing process and quality of the product, therefore,medical equipment that is compliant has been properly evaluated and inspected.
Medical devices marketed in the US must meet the UL60601 medical safety regulations, which are international standards. These regulations focus on the safety,performance, and usabilityof medical devices.
Are you interested in purchasing medical equipment? Search our directory to find a medical device manufacturer in your area.
If you are in the Orange, CA area, Onyx Healthcare USA, Inc is our featured company.
You can reach them at www.onyxhealthcareusa.com, or by calling 714-792-0774.