Medical device failure analysis services

Medical device failure analysis is an analytical service used to investigate the causes, mechanisms, and conditions that lead to malfunction, degradation, or fracture of medical devices and components. At Applus+ Laboratories, failure analysis of medical devices is performed to generate technical evidence related to material behavior, design performance, manufacturing processes, and in‑use conditions. 

This service is applicable across the product lifecycle, including development, verification, production, and post‑market evaluation. 

What is medical device failure analysis? 

Medical device failure analysis service is a well-structured investigation aimed at determining why a medical device or component did not perform as intended. The process examines physical damage, material properties, environmental influences, and operational conditions. 

Failure analysis medical device investigations are commonly initiated after product complaints, non‑conformities, unexpected test results, or field‑returned devices. 

Common root causes in medical device failures 

Failure analysis studies commonly address root causes such as: 

• Material defects or degradation 
• Fatigue, wear, or corrosion mechanisms 
• Manufacturing or assembly anomalies 
• Design‑related stress concentrations 
• Environmental or sterilization‑related effects 

Identifying these mechanisms supports technical decision‑making based on physical evidence. 

Benefits of medical device failure analysis 

Medical device failure analysis is used to: 

• Identify physical and material causes of failure 
• Provide data to support root‑cause investigations 
• Address quality and performance deviations 
• Evaluate design, process, or material changes 
• Support corrective and preventive action programs 

The resulting data contributes to product improvement and risk evaluation activities. 

Our medical device failure analysis techniques and capabilities 

Applus+ Laboratories applies a multidisciplinary approach to medical device failure analysis, combining microscopy, spectroscopy, mechanical testing, and material science expertise. 

Scanning electron microscopy (SEM) and EDS 

Scanning electron microscopy (SEM) combined with energy‑dispersive X‑ray spectroscopy (EDS) is used to examine fracture faces, wear patterns, corrosion features, and other imperfections as well as microstructural details. Elemental analysis supports identification of local material composition and contamination. 

Fourier transform infrared spectroscopy (FTIR) 

Fourier transform infrared spectroscopy (FTIR) is used to assess polymer composition, surface chemistry, and degradation products. FTIR analysis is commonly applied to investigate material changes, contamination, or unexpected residues. 

Metallurgical and material characterization 

In medical devices materials testing, metallography and material characterization techniques are used to evaluate microstructure, grain size, purity, heat treatment effects, coating characteristics, and material imperfections. These evaluations support investigation of mechanical failures and material performance issues. 

Failure analysis for different medical device classes 

Medical device failure analysis is applied across a wide range of device types and technologies:

Implantable devices and prosthetics 

Failure analysis for implantable devices focuses on fatigue fractures, wear mechanisms, corrosion, and material degradation under physiological conditions. 

Surgical instruments 

For surgical instruments testing, failure analysis evaluates mechanical integrity, impact damage, wear, joint failures, and functional deterioration after repeated use or reprocessing. 

Electronic medical equipment 

Failure analysis of electronic medical equipment assesses component damage, electrical failures, solder joint defects, corrosion, and environmental influences on electronic assemblies. 

Additional failure analysis capabilities 

Additional failure analysis applications include: 

• Packaging and container‑closure related failures 
• Coating delamination and surface damage 
• Particle and residue investigations 
• Failure evaluation after environmental or aging exposure 

Regulatory requirements and quality standards 

Medical device failure analysis activities are aligned with internationally recognized quality and risk management frameworks applicable to medical technologies. 

ISO 13485 and ISO 14971 

Examples of commonly referenced standards include: 

• ISO 13485 — Quality management systems for medical devices
• ISO 14971 — Application of risk management to medical devices 

Additional standards may be considered depending on device classification, materials, and failure mode investigated. 

Why choose Applus+ Laboratories for medical device failure analysis? 

Applus+ Laboratories provides medical device testing services through a global network of accredited laboratories with expertise in medical technologies, materials science and failure assessment. 

• Technical expertise in mechanical, chemical, and material investigations 
• Experience across implantable, non‑implantable, and active medical devices 
• Use of advanced analytical and microscopics techniques 
• Lifecycle support from development through post‑market evaluation 
• Global presence enabling consistent methodologies and reporting 

These capabilities position Applus+ Laboratories as a qualified partner for failure analysis of medical devices.