Applied Technical Services’ Family of Companies provides medical device mechanical testing to help ensure industry standard compliance and safety.
The Importance of Medical Device Testing
Medical devices are crucial to patient care. They directly impact human lives, producing vital observations and data. Devices must undergo testing to ensure optimal product functionality, efficiency, safety, and quality. Testing companies evaluate devices for these specific qualities before manufacturers can put them on the market.
How Medical Device Testing Works
Manufacturers must ensure that their medical devices are safe and effective by gaining proper assurance from regulatory bodies. They seek out medical device mechanical testing companies to conduct appropriate testing and analysis to eliminate any potential device risks.
Medical device mechanical testing companies play a significant role in every step of the approval process, from the early idea testing phase to final design validation and verification. Testing labs produce proper procedures, performance reports, and reviews. They also implement custom testing protocols to help manufacturers meet quality and safety standards set by regulatory entities, such as the FDA.
Types of Medical Device Mechanical Testing We Provide
- Axial compression testing
- Dedicated screw testing
- Fatigue testing
- Instrument and life cycle testing
- Lot verification testing
- Non-standard testing
- Shear testing
- Tensile testing
- Torque testing
- Wear and simulation testing
Our Family of Companies
We staff some of the industry’s most knowledgeable and skilled mechanical testing experts, engineers, certified lab technicians, machinists, regulatory consultants, and project managers. Our medical device testing laboratories conduct the most efficient and accurate testing services in order to help medical device projects succeed.
Our experts provide exceptional customer service seamless communication, and optimal solutions training. Our services are sensitive to the fast-paced product developmental environment, causing us to deliver reproducible and reliable results with rapid response times.
The ATS Family of Companies Offers:
- Additively manufactured component testing
- Comprehensive and proven solutions
- Custom testing procedures
- Experts in titanium subject matter
- Extensions of client’s team, providing timely execution and expert guidance
- Regulatory-ready test reports
- Trusted Reputation
Compliance Standards and Regulations
All ATS companies maintain ISO/IEC 17025 accreditation to ensure accurate reporting with dependable results. Our mechanical testing lab tests and evaluates medical devices under ISO and ASTM standards and features an extensive list of testing capabilities. These qualifications promote consistent excellence, improve operational efficiency, and reduce client costs.
In addition to our ISO/IEC 17025:2017 accreditations, all ATS companies employ an ISO-recognized Quality Management System (QMS), which upholds our organization-wide dedication to confidentiality. Each of our employees undergoes in-depth training in QMS and document handling, ensuring all client relationships are strictly confidential.
Contact Us
Our medical device mechanical testing assures manufacturers that their product is safe and functional. Ranging from tongue depressors to heart valves, we will verify that your is able to achieve proper functionality. Contact the medical device mechanical testing experts at ATS’ Family of Companies today to request a free quote or schedule services.
