Heart Valves Used By Doctors

Medical Device Testing Companies

The ATS Family of Companies’ proven expertise in the relevant internationally recognized analysis methods allows us to be one of the industry’s best medical device testing companies. We offer an expert team of highly trained engineers and a 24-hour operation to help clients execute their test plans.

What Medical Devices Do

Medical devices help solve healthcare problems. They help save human lives from serious disease or injury and cure health conditions, along with proper medication and treatment. As these are life-saving devices, validating their quality is vital before putting them on the market.

Why Medical Device Testing Is Necessary

Having high product quality us essential in the medical industry. Not only is quality morally and ethically necessary for manufacturing companies, but multiple organizations (such as the United States Food and Drug Administration (FDA)) mandate it by enforcing strict standards. Under these guidelines, manufacturers must document every step of their medical device’s development to meet safety and functionality requirements.

A manufacturer can obtain clearance or approval for their product by working with medical device testing companies. This provider will perform extensive analysis on the product, verifying that it is safe and suitable for patient use.

What Sets Us Apart from the Rest

The ATS Family of Companies has been a trusted partner in medical device testing for over 20 years. Our clients’ test results help them meet regulatory requirements imposed by numerous agencies, including FDA and CE marketing approval. We provide our clients with high-quality medical device testing services by providing rapid responses, reliable test results, and professional reports. Furthermore, we have among the highest number of accredited medical device testing methods of all United States medical device testing companies.

Medical Device Testing We Offer
Accreditation and Quality Standards

The ATS Family of Companies holds an ISO/IEC 17025:2017 accreditation (A2LA Cert No. 2142.01) for the highest number of medical device testing methods of any United States company. Our lab performs medical device testing and evaluations according to recognized ASTM and ISO standard specifications appropriate to our testing application. Both these qualification aspects set the Family of Companies apart from our competitors by reducing costs, establishing credibility, and improving efficiency.

The Family of Companies has medical device testing labs that equip manufacturers with the tools to get it right from the start. We get medical device manufacturers to market faster for less by helping them uphold their quality and safety standards.

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Medical Device Testing