Two Medical Device Experts Working To Fix Equipment In A Laboratory

Medical Device Testing Services

The ATS (Applied Technical Services) Family of Companies offers medical device testing services for clients who need FDA approval on their medical devices.
Why Medical Device Testing Services Are Important
Medical devices are vital to patient care, directly impacting human lives by producing critical data and observations.
Medical device testing services are an essential step in the developmental process of medical devices as they help ensure product quality, safety, and efficiency. Testing for these qualities is a mandatory part of the process when getting a product out on the market.
How Medical Device Testing Works
Manufacturers must prove that their medical devices are safe and effective by supplying regulatory bodies with proper assurance. They seek out medical device testing services to perform appropriate testing and analysis to eliminate potential risks.
From early idea testing to final design validation and verification, medical device testing serves a role in every step of the process. Our labs produce development procedures, as well as performance reviews and reports. Furthermore, they implement custom testing services to help manufacturers meet stringent safety and quality standards set by the FDA and other regulatory bodies.
Types of Medical Device Testing We Offer:
Tensile testing measures how much force will break a specimen or composite and the amount of stretch it is susceptible to before reaching a breaking point. This test provides knowledge about the ductility of a metallic material, its yield strength, and its tensile strength.
Taber abrasion testing performs accelerated wear testing to evaluate abrasion resistance. This test supports quality and process control, research and development, and material evaluation projects.
Torsion testing twists a sample along an axis or fixed point. This test obtains details such as shear modulus, shear stress, maximum torque, the interface between two materials, and the angle of breakage on a material.
Fatigue testing provides manufacturers with a critical understanding of the material and component performance in real-world scenarios over time. This test also identifies critical locations, validates the safety of structures sensitive to fatigue, and generates data such as crack growth and fatigue life.
Shear testing applies stress to a sample so that it experiences sliding failure on a plane parallel to any opposing froes. This test determines the specimen’s shear strength.
Lot verification testing provides FDA with real-time information to monitor the quality of each batch of products it regulates.
Instrument & life cycle testing apply cyclical mechanical forces to a unit inside a controlled environment. This test helps manufacturers meet the threshold for compliance and ensures quality for customers.
Wear & simulation testing allows manufacturers to evaluate the wear performance of designs and materials under intended service conditions.
Dedicated screw testing encompasses driving torque, pullout, lever, shear, and fatigue testing.
Non-standard/custom testing provides help to clients wanting to test their medical devices with no set standard.
Our Team of Mechanical Testing Experts
We employ the industry’s most knowledgeable and skilled mechanical testing experts, engineers, lab technicians, machinists, regulatory consultants, and project managers. Our medical device testing laboratories provide the most efficient and accurate services to help our client’s projects succeed. All our experts offer the best customer service, communication skills, and training for optimal solutions.
Our Testing Scope Includes:
Compliance with Standards and Regulations
We maintain an ISO/IEC 17025:2017 accreditation for the highest number of medical device testing methodologies out of any corporation in the US. Our lab tests and evaluates medical devices according to ISO and ASTM standards appropriate to the testing application type. These qualifications set us apart from competitors by promoting consistent excellence, improving operational efficiency, and reducing client costs.
Our medical device testing laboratories provide manufacturers with the knowledge they need to design safe and functional products. We get manufacturers’ medical device products on the market faster by aiding them with safety and quality standards. Reach out to us today for a free quote on our services!

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Medical Device Testing