NG Scale provides engineering services and a turnkey testing solution for any company needing to study product durability or life cycle fatigue. We have a specific focus on medical devices.

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Solutions

Outsource Testing

Save engineering resources, space, and time with our remote monitoring fatigue facility. Test multiple iterations simultaneously.

Design Control

Our team can help you navigate product development from prototype to manufacturing and FDA approval

Testing Equipment

Get help choosing the right equipment or work with our team to build a custom solution that meets your needs

On-site Testing

We can come to you and build a fatigue testing room that fits your company's requirements

Outsource Fatigue Testing

Our team is ready to go with expertise and equipment needed to help you understand the lifecycle durability of your products. By working with us, your company eliminates the need to hire engineers to design and qualify new fatigue test methods, or train new technicians to run and monitor the testing over the coming months.
We have the ability to test multiple product iterations simultaneously, ensuring you get to your final design quickly. After a final design is chosen, we immediately begin qualification testing.
All testing is done at our facility, with remote monitoring of samples available to clients, along with regular status updates and data reporting.
Our facility performs all required test equipment calibration, qualification, and preventative maintenance.
Our test equipment can be configured for the most common environments-room temperature, dry heat, high humidity, or submerged in heated saline baths.

Design Control

Our company is well versed in the necessary phases of product design, as a means of ensuring project success and as a part of industry regulatory requirements.
For medical devices, we have unique knowledge of the FDA design control process, and can offer consulting on your medical device development from prototype to commercial launch.
We understand how this fits into your design control process

Testing Equipment

Our single test unit is perfect for early stage testing of prototypes and iterations. There are many vendors for a variety of testing equipment. While these are great solutions, early stage companies desire a more cost effective and hands on option.
The mobile version is great for field testing and demonstrations at shows or conferences.
If you need a custom build, we will design equipment to meet your specific needs.

On-site Test Racks

If other available testing solutions do not work for you, we can come to your location and build a fatigue test system to meet your unique needs.

What is fatigue testing?

A fatigue test helps determine a material’s ability to withstand cyclic fatigue loading conditions. By design, a material is selected to meet or exceed service loads that are anticipated in fatigue testing applications. Cyclic fatigue tests produce repeated loading and unloading in tension, compression, bending, torsion or combinations of these stresses. Fatigue tests are commonly loaded in tension – tension, compression – compression and tension into compression and reverse.

Why do medical devices require fatigue testing?

If your product needs to maintain its design function over a period of time, then those functions need to verified with testing over the claimed product lifecycle.

In some cases, this can just be justified. However any products that experience a stress load over time will most likely need some type of test method developed.

We can help you understand the needs for verification testing, and confirm any test plans within our industry network based on your target market and regulatory environment.

Some info on FDA's 21 CFR

We consider FDA's established requirements as we design your test methods. The FDA regulates entities that manufacture medical devices in the United States. Section 820 of the Code of Federal Regulations Title 21 (21 CFR 820) requires manufacturers to establish and follow Quality Systems (QS) to help ensure that products consistently meet applicable requirements and specifications. Design Controls are applied to the product development cycle so that the design input requirements are translated into a device design conforming to those requirements.

Application of Design Controls to Waterfall Design Process , Medical Devices Bureau, Health Canada

In addition to procedures and work instructions necessary for the implementation of design controls, policies and procedures may also be needed for other determinants of device quality that should be considered during the design process. These can include risk management, device durability, and device evaluation, etc.

Design Verification (21 CFR 820.30(f)), requires:

Each manufacturer shall establish and maintain procedures for verifying the device design.
Design verification shall confirm that the design output meets the design input requirements.
The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the Design History File (DHF).

Some manufacturers erroneously equate production testing with verification. Whereas verification testing establishes conformance of design output with design input, the aim of production testing is to determine whether the unit under test has been correctly manufactured.