Medical Device Regulatory Compliance Testing

The Applied Technical Services Family of Companies (FoC) provides medical device regulatory compliance testing for manufacturers. A medical device is an instrument, material, appliance, or implant used to diagnose, treat, and prevent injuries or illnesses. These devices range from single-use devices such as catheters and syringes to complex spinal implants. Our medical device testing lab helps manufacturers comply with regulatory requirements and secure eligibility in the marketplace.

Our Medical Device Testing Capabilities

Our experienced medical device testing experts use their decades of collective experience to conduct a wide range of medical device tests and evaluations. We evaluate medical devices in various conditions to gather information and evaluate how devices respond to specific conditions and stresses. The information we collect assists manufacturers as they do the following:

We offer an extensive list of dental, joint, spinal, and extremity medical device testing services, including:
Why is Medical Device Regulatory Compliance Important?
Medical device regulatory compliance ensures the safety and effectiveness of healthcare products. Established by entities like the U.S. FDA or the European Medicines Agency, these regulations set design, manufacturing, quality control, labeling, and post-market surveillance standards. Third-party medical device testing labs ensure that medical devices meet these rigorous standards, reducing the risk of harm. Regulations also promote transparency and accountability by providing healthcare professionals and consumers with accurate information about the device’s risks and benefits. This transparency fosters trust in the medical device industry, reassuring stakeholders that the products are thoroughly tested and monitored. Failure to comply with regulatory standards can lead to serious legal, financial, and reputational consequences, as well as potential patient harm.
Our Commitment to Quality
The Applied Technical Services Family of Companies upholds internationally recognized quality standards to ensure our clients receive high-quality services from various departments. We provide professional inspection, testing, and consulting engineering services for commercial and industrial clients in multiple industries. Our A2LA-accredited facilities offer the following services:
Please submit a web request or call +1 (888) 287-5227 to speak with inquire about our medical device regulatory compliance testing.

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Medical Device Testing