Medical device mechanical testing services

Medical device mechanical testing is a critical process that ensures the safety, reliability, and performance of medical devices before they reach the market. At Applus+ Laboratories, we provide comprehensive mechanical testing for medical devices, helping manufacturers meet stringent industry standards and regulatory requirements.  

What is mechanical testing for medical devices? 

Medical Device Mechanical Testing is the process of evaluating how a medical device behaves under forces such as tension, compression, torsion, fatigue, and multi‑axial loading. These tests determine whether the device can withstand real‑world mechanical stresses throughout its intended lifespan.  

As part of mechanical testing for medical devices, engineers assess strength, stability, wear, structural integrity, and material performance under controlled conditions that simulate clinical use. Mechanical testing is essential for meeting international certification pathways—including FDA clearance and EU MDR—supported by strict medical devices mechanical testing regulations that require documented performance data. 

Medical device mechanical testing benefits 

Mechanical testing provides critical assurance that implants, instruments, and components will remain safe and functional during clinical use. Benefits include reliable performance verification, early detection of design weaknesses, improved patient safety, compliance with global regulatory standards, and evidence generation for submission to notified bodies and regulators. For manufacturers, this testing reduces the risk of product failure, accelerates certification processes, and supports competitive product development.  

• Ensures product safety and reliability 
• Identifies potential design weaknesses before market release 
• Supports compliance with medical devices mechanical testing regulations 
• Reduces the risk of product recalls and liability 
• Enhances market acceptance and trust among healthcare professionals 

Our medical device mechanical testing capabilities 

At Applus+ Laboratories, we offer a wide range of mechanical testing services tailored to the unique needs of the medical device industry. 

Orthopedic implants  

Applus+ Laboratories performs fatigue, wear, corrosion, and strength assessments for joint prostheses, osteosynthesis devices, spinal implants, trauma implants, and associated components. Testing includes advanced wear simulation for hip, knee, shoulder, patella, and ankle joints, following standards such as ISO 14242, ISO 14243, and ISO 22622. 

Dental implants and prosthetic components  

We evaluate mechanical strength, dynamic loading behavior, and connection stability for endosseous dental implants and prosthetic interfaces, including testing aligned with ISO 14801. 

Surgical instruments  

Our testing includes impact resistance, fatigue performance, torsion strength, and cyclic durability—particularly for impact‑loaded surgical tools such as hip cup positioners. We also develop custom rigs when no standardized test exists. 

Other capabilities 

• Trauma and osteosynthesis products 
• Skin adhesives and wound closure devices 
• Test in physiological bath 
• Custom test procedures for innovative devices 

Key methods in mechanical testing for medical devices

Fatigue and durability testing  

Fatigue testing simulates long‑term cyclical loading to determine how devices respond to repetitive stresses. This is essential for implants like hip stems, spinal rods, and plates that must endure millions of cycles. 

Static and dynamic testing  

We perform static tests (compression, bending, tensile) and dynamic tests to evaluate performance under controlled loads, helping identify structural stability, deformation limits, and failure thresholds. 

Torsional and multiaxial loading  

Torsion and multi‑axis load simulations replicate complex biomechanical conditions. Our multi‑axis simulators recreate physiological movements and combined forces experienced by implants during daily activity. 

Finite element analysis (FEA) and simulation  

FEA supports mechanical testing by predicting stress concentrations, deformation patterns, and failure zones. Simulation complements physical testing during R&D and helps optimize device design before producing prototypes. 

Other methods 

• Wear testing for medical devices
• Corrosion testing for medical devices
• Impact and drop testing 

Regulatory standards for medical device mechanical testing 

Compliance with medical devices mechanical testing regulations is essential for market approval. Our testing services align with international standards such as EU MDR, FDA and NMPA. Applus+ Laboratories works with industry standards including: 

• ISO 13485 - Medical device quality systems 
• ISO 14801 - Dynamic loading for dental implants 
• ISO 7206 series - Hip joint prostheses 
• ISO 14242 - Wear testing for joint prostheses 
• ISO 17853 - Particle analysis 
• ASTM F543 - Metallic bone screws 
• ASTM F1717 - Spinal implant constructs 
• ASTM F1798 - Spinal arthrodesis connections 
• ASTM F2077 - Intervertebral body fusion devices 
• ASTM F1877 - Damage analysis, and other relevant guidelines. 
• ASTM F04.25.02.02 - Expulsion 
• ISO 14243 - Wear testing for knee prostheses 
• ASTM F2582 - Impingement testing 
• ASTM F3738 - Third-body particles wear test 
• ASTM F3090 - Fatigue Testing of Acetabular Devices for Total Hip Replacement 
• ASTM F3143 - Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings 
• ASTM F3141 - Total Knee Replacement Loading Profiles 
• ASTM F1160 - Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings 
• ASTM F1044 - Shear Testing of Calcium Phosphate Coatings and Metallic Coatings 
• ASTM F1047 - Frying and Braising Pans, Tilting Type 
• ASTM F1820 - Determining the Forces for Disassembly of Modular Acetabular Devices   
• ASTM F2009 - Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses 

Why choose Applus+ Laboratories for medical device mechanical testing services? 

Applus+ Laboratories is an internationally recognized, ISO17025–accredited testing body specializing in implant and device mechanical assessment. With decades of experience, advanced multiaxis simulators, custom rig development, accredited wear and fatigue labs, and deep regulatory expertise, we support manufacturers through preclinical testing, R&D, certification preparations, and postmarket performance investigations. Our global footprint and rapid turnaround times make us a trusted partner for all aspects of mechanical testing for medical devices. 

• Decades of experience in medical device mechanical testing 
• State-of-the-art equipment and custom test rigs 
• Expertise in regulatory compliance and test method development 
• Comprehensive support from test planning to final reporting 
• High quality follow-up on the study 
• Possibility of accelerated study 

All tests can be conducted under conditions that replicate the physiological environment of the human body.