The Applied Technical Services Family of Companies (FoC) evaluates bone implants in compliance with ISO 9585 standards. Medical devices improve the lives of millions of people worldwide, and their safety and effectiveness are essential to maintaining the quality of life for these people. Our medical devices testing lab offers comprehensive testing services that ensure our clients’ compliance with laws, standards, and regulations.
What is ISO 9585?
The International Organization for Standardization (ISO) created the ISO 9585 standard as a series of guidelines for experts evaluating the stiffness and strength of bone plates. The standard’s objective is to evaluate the reliability, safety, and functionality of bone plates to ensure the device is effective for the end user.
Our ISO 9585 Testing Services
Our state-of-the-art medical device testing lab proudly offers ISO 9585-compliant services that support manufacturers, healthcare providers, and patients. Our dedicated team specializes in comprehensive tests to confirm a device’s ability to perform as expected while ensuring its compliance with relevant regulations. In addition to our ISO 9585-compliant tests, we offer a wide range of medical device tests, such as:
- Fatigue tests
- Life cycle tests
- Lot verification tests
- Shear tests
- Simulation tests
- Torsion tests
- Tensile tests
We recognize the importance of quality and safety in the healthcare industry, so our A2LA-accredited lab remains committed to helping adhere to regulations.
The Importance of ISO 9585-Compliance
ISO 9585 compliance is mandatory for manufacturers seeking to have their bone plates eligible for use in medical procedures. Adherence to the standard also boosts consumer trust in the product as end users can rest assured knowing the product was thoroughly evaluated by the proper authorities. Compliance is also beneficial in protecting manufacturers and medical providers from potential lawsuits that could arise following issues or injuries experienced by patients who receive the implant.
About the ATS FoC
In our nearly 60 years of business, the ATS has steadily grown in the Family of Companies we are today. With locations scattered across the US, we have made it our mission to make our world-class testing, inspection, analysis, and calibration services accessible to clients across various industries. We offer both in-lab and on-site services designed to effectively and efficiently address our clients’ concerns. Please call +1 (888) 287-5227 to learn how our specialists can help your business today.
