Mechanical Testing – Ensuring
Strength, Durability & Performance
of Medical Devices
Mechanical testing is a critical step in validating the safety, reliability, and performance of medical devices under real-world conditions. It evaluates properties such as tensile strength, compression resistance, fatigue life, impact resistance, and flexural performance to ensure devices can withstand the stresses they will encounter during use. At SIMA LABS, we provide comprehensive mechanical testing for implantable devices, surgical instruments, orthopedic components, dental devices, and disposable medical products in compliance with ISO, ASTM, and FDA standards. Using advanced testing equipment and controlled laboratory conditions, we help manufacturers meet regulatory requirements and assure consistent product quality.
Why Choose SIMA LABS for Mechanical Testing?
- Global Standards Compliance – ISO 10993, ISO 7206, ASTM, and FDA guidelines followed.
- Comprehensive Mechanical Parameters – Tensile, compression, fatigue, impact, hardness, and flexural tests.
- Advanced Testing Equipment – Universal testing machines, fatigue testers, impact testers, and more.
- Wide Device Coverage – Implants, surgical tools, catheters, prosthetics, dental devices, and disposables.
- Regulatory-Ready Documentation – Detailed reports for CE marking, FDA submissions, and ISO certification.
- Expert Team – Experienced engineers and material scientists specializing in medical device validation.
35+ Years of SIMA LABS – Mechanical Testing You Can Trust
SIMA LABS is NABL accredited and approved under BIS for comprehensive mechanical testing of medical devices in compliance with ISO, ASTM, EN, and FDA standards. All tests are conducted in controlled laboratory environments using validated methods to ensure product safety, performance, and regulatory acceptance for both domestic and international markets.
We provide a wide range of mechanical performance evaluations for medical devices to verify their strength, durability, and reliability.
Scope of Testing:
Mechanical Properties:
Tensile strength & elongation
Compression resistance
Flexural strength & modulus
Hardness testing (Shore, Rockwell, Vickers)
Fatigue life & cyclic loading
Impact resistance & drop testing
Torsional strength & torque testing
Products Covered:
Orthopedic implants & fixation devices
Surgical instruments
Catheters, stents, and guidewires
Dental devices & prosthetics
Disposable medical devices
Technology Used:
Universal Testing Machines (UTM)
Dynamic Fatigue Testing Systems
Impact Testing Machines
Hardness Testers
Regulatory Compliance:
ISO 10993 (biomechanical requirements for implants)
ISO 7206 (hip prostheses)
ASTM standards for material and device testing
CE & FDA submission requirements
With precision equipment, international standard compliance, and expert analysis, SIMA LABS ensures your medical devices meet the highest benchmarks for mechanical safety and performance.
Trusted by leading brands
our customers are the driving force behind our growth and innovation
Precision. Compliance. Innovation
Our Expertise
At Sima Labs, we specialize in advanced analytical testing, regulatory compliance, and quality assurance across the food, pharmaceutical, and environmental sectors—delivering reliable results with international standards and technical excellence.
Residue Analysis
SIMA Labs offers residue testing and compliance with ELV, RoHS, REACH, and EN71 standards
Microbiological Analysis
SIMA Labs provides microbiological testing and indoor air quality monitoring.
Molecular Biological Analysis
SIMA Labs offers GMO, allergen, pathogen testing, event identification, and pharma analysis for safety and compliance.
Method Development and Validation Studies
SIMA Labs provides stability testing, drug analysis, quality checks, lab consultancy, training, and R&D support.
Environment Monitoring
SIMA Labs offers environmental testing for pollutants, gases, and air quality monitoring.
Get In Touch
At SIMA Labs, we’re proud to offer our expertise in analysis and research to help you find the right solutions.
Let’s Connect – Book Your Appointment Today!
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+(91)-(11)-43854300