Performance Testing

Accurately Evaluate Performance to Ensure Medical Safety

Reliability assessment with advanced models.
Regulatory support team standby for performance standards compliance.
Customized performance testing plans.
One-stop medical device analysis services including other related analysis projects.
Continuous improvement based on industry feedback.
Rigorous quality control system.
Professional team.
Advanced laboratory equipment.
Timely response.

Performance testing serves as a vital approach to assessing the overall performance of medical devices. It enables manufacturers to evaluate risks, usage efficacy, and accuracy, and ascertain safety during use. Spanning from design and development to production and application, performance testing is a fundamental and decisive element for gauging the comprehensive quality of medical devices. Its outcomes directly bear on the operational reliability of medical devices in clinical practice, thereby affecting medical decision-making and patient treatment experiences.

AltaNovate specializes in providing professional and systematic performance testing services for medical devices, which focus on various aspects such as functionality, reliability, and safety of the devices, along with regulatory support services for market access. Contact us for any needs.

Fig.2 Workflow of Performance Testing

Our Service

Different types of medical devices usually require different performance tests. For example, surgical instruments mainly need to undergo mechanical performance tests; diagnostic medical devices focus on acoustic and imaging performance tests; and intelligent interactive devices require software tests.

AltaNovate pays attention to the characteristics of different devices and provides systematic and customized performance testing services for various products, including physical performance, chemical performance, and safety performance, etc.

Testing Item	Testing Contents	Applicable Medical Devices
Physical Performance	Measurement of size and shape, mechanical performance tests such as strength and stiffness, determination of flexibility and elasticity, analysis of stability and operational force characteristics, evaluation of rotational and movement performance, weight measurement, etc.	Various surgical instruments, orthopedic implants, catheters and guidewires, portable medical devices, etc.
Chemical Performance	Identification of chemical components, assessment of chemical stability, detection of leachables and extractables, etc.	Plastic medical devices, infusion bags, dental restoration materials, etc.
Electrical Performance	Verification of electrical safety, calibration of electrical parameters, validation of electromagnetic compatibility, etc.	Electrosurgical equipment, medical ultrasonic diagnostic devices, electrocardiographs, etc.
Optical Performance	Evaluation of imaging quality, determination of optical parameters, etc.	Medical endoscopes, microscopes, ophthalmic surgical microscopes, etc.
Acoustic Performance	Measurement of acoustic output parameters, testing of acoustic sensitivity, etc.	Ultrasonic diagnosis and treatment devices, hearing aids, stethoscopes, etc.
Reliability Testing	Software reliability analysis, prediction of service life, verification of environmental adaptability, etc.	Various medical devices, such as dental handpieces, computed tomography (CT) devices, artificial joints, etc.

Need Performance Testing?

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AltaNovate is your top choice for medical device analysis! We provide one-stop analysis services covering biocompatibility testing, sterility testing, mechanical testing, etc. Regardless of the type of your medical device and the specific testing service it requires, we are capable of offering customized testing solutions. Contact us now for free initial consultations and customized analysis.

Related Services

Sterility Testing/ISO 11737 Series

Chemical Analysis

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