Medical Device Testing Services

Accelerate your medical device certification with Element's comprehensive safety testing to the Medical Device Directive.

Accelerate your wireless medical device’s journey to market with Element's comprehensive testing solutions. From remote patient-monitoring systems to IoT-enabled devices – Learn More.

Our testing service verifies the mechanical integrity of bone plates, screws, and fixation devices through ASTM-standard fatigue, bending, and torsion evaluations, providing critical data for regulatory compliance and trauma reliability.

Element offers comprehensive cardiac and endovascular device testing, providing fatigue and durability analysis to support regulatory compliance and product reliability for stents, heart valves, pacemaker leads, and more.

Our automated chemical compatibility testing verifies that medical devices withstand corrosive disinfectants, offering comprehensive, fast, and reliable evaluations that preserve product integrity and extend device longevity in harsh cleaning environments.

Element's Cleanliness and Microbiological Testing service validates cleaning processes, evaluates microbial loads, and performs bioburden, endotoxin, and cytotoxicity tests to reduce contamination risks and support device performance and patient safety.

Element delivers comprehensive clinical validation testing for medical devices and wearables, managing study design, recruitment, testing, and data analysis. Our complete solutions help overcome regulatory challenges and accelerate product development.

Element provides comprehensive blood pressure monitor clinical validation testing—from protocol design and participant recruitment to data analysis—leveraging invasive and non-invasive methods to overcome regulatory challenges and deliver precise device performance.

Get expert consumer electronics testing to accelerate your market entry. Element's accredited EMC, safety & wireless compliance services facilitate smoother market entry.

Element provides clinical validation testing for heart rate monitors using human and simulator data, meeting regulatory standards while delivering accurate performance. Their expert guidance addresses key accuracy challenges.

Element's human factors and usability testing simulates real-world device use to reveal user errors and optimize performance. The service supports FDA guidelines and enhances overall device safety and effectiveness.

Element's pulse oximeter clinical validation service provides comprehensive human testing that delivers real-world, high-quality data to support regulatory submissions and significantly optimize device performance across diverse clinical settings with precision.

Element offers expert-led respiratory rate monitor clinical validation testing, covering protocol design, participant recruitment, and regulatory-ready reports for streamlined submissions.

Element provides clinical validation testing for sleep monitoring devices, supporting regulatory submissions and optimising device safety through expert-led data analysis and participant studies.

Element offers expert clinical validation testing for temperature monitoring devices, supporting regulatory requirements and fast-tracking your product to market with comprehensive study management.

Element provides coating integrity and particulate testing for intravascular devices, helping manufacturers meet safety standards, improve device performance, and comply with regulatory guidelines.

Element offers electrochemical corrosion testing to identify material risks, enhance durability, and support informed material selection across industries.

Element offers expert foot, ankle, and shoulder implant testing, covering fatigue, wear, and constraint analysis to support orthopedic device development and regulatory submissions.

Element offers heart valve device testing, simulating real-life conditions to evaluate durability, fatigue, and performance, helping manufacturers develop reliable cardiovascular implants.

Element provides testing and certification to IEC 60601 to assess the safety and essential performance of electrical medical devices.

We offer comprehensive testing services for catheters and balloons under ISO 10555 standards for testing intravascular sterile use catheters.

Element offers ISO 11070 guidewire testing, evaluating cardiovascular devices for performance, durability, and safety through simulated use, tensile strength, torque, and flexibility tests.

Element provides ISO 14801 dental implant fatigue testing to support regulatory approval. Our experts deliver precise data on implant durability, lifecycle, and performance for safe market entry.

Element provides ISO 7206-compliant hip joint prosthesis testing, assessing endurance, fatigue, and compression to support safe, high-performing medical devices worldwide.

Element offers expert knee implant testing, including fatigue, wear, and constraint analysis, to support device design, feasibility studies, and regulatory compliance.

Battery safety testing for medical devices, assessing performance, reliability, and compliance with international standards to support safe use in healthcare settings.

Element provides EMC testing and certification for Class I-III medical devices, helping manufacturers meet global regulatory standards and accelerate market entry with expert guidance and accredited laboratories.

Element offers expert medical device regulatory consulting, guiding you through design, risk analysis, and FDA submissions for efficient product approval.

Accelerate your medical device safety testing with Element's end-to-end services. From design consultation to global certification, we navigate complex regulations so you can launch faster.

Element evaluates nickel icon release from nitinol and other nickel-rich medical devices to help medical device manufacturers characterize nickel ion leaching.

Element offers advanced occluder device testing, evaluating durability and fatigue to support safe, long-term cardiovascular performance through expert-led, specialized testing protocols.

Accelerate orthopedic device development with Element's comprehensive testing services. From hip to spinal implants, we ensure regulatory compliance while reducing time-to-market. Expert support at every stage—prototype to commercialization.

Pacemaker lead testing evaluates safety, performance, and compliance with industry standards. We simulate real-world conditions to help manufacturers bring safe, reliable cardiovascular devices to market.

Pin on disk wear testing evaluates material wear performance under controlled conditions. Ideal for regulatory requirements and material comparison, Element's advanced methods and expertise deliver reliable insights.

Element provides porous structure testing for medical devices, evaluating mechanical and metallurgical properties to support regulatory compliance, product development, and supplier validation.

Element provides rated burst pressure and leak testing for medical devices, ensuring safety and compliance with ISO standards. Services include fatigue, flow rate, and pressure-diameter analysis for balloons, catheters, and grafts.

Comprehensive life cycle validation for reusable medical devices. Supporting compliance, patient safety, and regulatory approval through expert testing and risk mitigation.

Element's expert validation services for reusable medical devices ensure your equipment is GLP compliant, protecting your staff and your patients.

Our cardiovascular device testing experts have extensive experience designing custom mock vessels for pulsatile fatigue testing and other test methods for devices such as stents, occluders, and heart valves.

Element's trusted medical device testing covers fusion and non-fusion spinal devices, as well as predicate components, to ensure their durability and lifespan in use.

Element provides expert stent testing services to validate cardiovascular device compliance, durability, and performance. Our comprehensive testing meets regulatory standards, supporting safe and effective device

Element provides expert prefilled syringe testing, assessing functionality, integrity, and compliance with ISO standards. Our services help medical device manufacturers meet regulatory requirements with precision and confidence.

Element can handle every aspect of your medical device wear test program, no matter how long you want the tests to run for or how many repeats you need.

With Element as your medical device testing partner, you’ll enjoy the benefit of a single comprehensive supplier across feasibility, R&D and prototype trials, through product development, regulatory validation and production quality control.

Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch. Our Engaged Experts are ready to assist.

Element offers complete hand sanitizer efficacy testing, including USP 611 GC-FID and GC-MS methods, to verify alcohol content, purity, and safety, helping products meet regulatory standards.

Comprehensive medical grade polymer testing to support device development, improvement, and compliance with regulatory standards. Tailored solutions address safety, quality, and performance needs in medical devices.

Element's experts provide failure analysis of polymer-based medical devices, which is critical to ensuring that process or material improvements can be made to prevent repeated failures.