RICOR Systems Inc. is a recognized provider in the medical device manufacturing industry, offering product safety testing and certification services for Class I, II, and III electronic medical devices. Leveraging our FDA registration and ISO 13485:2016 certification, our engineering and manufacturing capabilities are structured around executing meticulous safety testing and validation processes that adhere to the highest standards, including IEC 60601 and UL 2601 safety requirements. Our integrated approach ensures that our clients receive unparalleled support, from concept through validation to full-scale manufacturing, guaranteeing devices that are not only innovative but also meet rigorous safety and quality benchmarks, supported by an expert engineering team and state-of-the-art facilities.
Safety Testing: F2 Labs is a full-service safety testing organization. Our safety laboratories are set-up to test/evaluate products for the United States, Canada, Europe, and International Certifications. Our safety facilities are A2LA Accredited, and our safety test data and evaluations are accepted by an OSHA...
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Designing the Future of MedTech From Concept to Commercialization
HaA Product Development implements a comprehensive product safety testing strategy, focusing on user feedback & testing alongside quality assurance, including cognitive walkthroughs, heuristic and use-related risk analysis, and both formative and summative evaluations to ensure medical devices exceed all industry safety standards including FDA QSR 21 CFR 820 and ISO 13485:2016. Supported by rigorous engineering and our integrated approach, we provide unparalleled support and expertise in regulatory compliance, engineering planning, and iterative design testing, ensuring every device is perfectly tuned for user safety and market success from conception through manufacturing.
PSN Labs sets the standard in product safety testing with its ISO/IEC 17025:2017-accredited state-of-the-art testing laboratory integrated with comprehensive engineering service, delivering precise and reliable material and product testing solutions to meet your specific needs. Our rigorous ASTM Proficiency Testing participation ensures the highest data accuracy. With a unique blend of expert analysis, cutting-edge technology, and a passionate educational approach, our testing services provide more than just numbers—they deliver insightful interpretations that drive your product's performance and safety in application. When you test with PSN, you have a team of experts working for you.
NAMSA provides medical device testing, leveraging over 55 years of industry experience and operating state-of-the-art laboratories worldwide to conduct over 100,000 tests annually. With an unmatched portfolio of services, including biocompatibility, biological safety, and a comprehensive suite of tests to navigate regulatory pathways efficiently, NAMSA streamlines the journey from product development to market. Our in-house team of experts utilizes rigorous methodologies and innovative processes, and our wide-ranging services span from notified body selection and pre-IDE preparation to post-market support, leveraging our deep understanding of international requirements to expedite market entry while prioritizing patient safety and healthcare innovation, ensuring cost-effective solutions and faster market introductions for medical devices that improve patient lives.
At National Instruments (NI), now part of Emerson, we empower organizations to transcend traditional performance benchmarks through an innovative suite of product safety testing services, leveraging automation, standardization, and digital transformation. Our holistic approach includes cutting-edge tools and methodologies, like LabVIEW and TestStand, that streamline measurement automation, enhance test system management, and ensure rigorous safety compliance across the entire product development lifecycle. With NI, businesses gain not only in operational efficiency and reliability but also in forging a competitive advantage through superior product quality and faster time-to-market, ensuring the safety and satisfaction of the end-user.
Fluke Corporation advances product safety test and measurement tools, delivering unmatched precision and reliability to keep businesses and industries across over 100 countries efficiently operational with Fluke Biomedical, which provides cutting-edge biomedical testing equipment, ensuring healthcare professionals can guarantee the safety, accuracy, and reliability of critical life-support and diagnostic devices. Our comprehensive range of products, from defibrillator analyzers to patient simulators and digital pressure meters, is designed to meet global standards, offering precise and dependable testing solutions for a variety of medical devices, including electrical safety, pressure, flow, and phototherapy. With over 20 years of commitment to the healthcare industry, Fluke Biomedical empowers you with rugged, portable, and user-friendly instruments, enhancing device performance and ultimately ensuring patient safety.
Micro Measurement Labs is an independent contract testing laboratory providing accurate, expert advice with most any particle size or count related application. Our particulate matter testing laboratory excels in particle type, source, and elimination testing; best methods for compendial particulate testing; solving particulate matter problems in pharmaceutical & medical device applications; container, formulation, and process trouble-shooting; particulate contamination testing; and particle size distribution and nanomaterials. Other services include method development and method validation, on site calibrations, and Performance Qualification designed to monitor instrument accuracy between calibrations.
ADMET Inc. specializes in delivering innovative solutions for material safety testing, offering a vast portfolio of testing machines, including electromechanical and hydraulic systems, ideal for a multitude of testing requirements like tension, compression, and fatigue across diverse materials from aerospace composites to medical devices. Our testing systems, complemented by advanced eP2 and MTESTQuattro controllers, are designed to enhance efficiency and precision in laboratories by streamlining processes, offering comprehensive data analysis that meets global standards, and ensuring user-friendly operations. With over 25 years of expertise, ADMET's commitment to quality and support encompasses not only the supply of state-of-the-art equipment but also retrofitting services and free lifetime application support, ensuring our clients' testing capabilities are always at the cutting edge.
Tinius Olsen offers an extensive range of product safety testing solutions tailored specifically for the medical industry, ensuring that medical devices meet rigorous standards for reliability and compliance throughout their product lifecycle. Our expertise includes advanced testing systems such as UTMs, melt flow indexers, and automated systems, supported by comprehensive service and support to manage everything from initial risk assessments to certification processes. With over 150 years of experience, we partner with medical device manufacturers globally, leveraging cutting-edge technologies through comprehensive support, Bluetooth, and wireless testing software, as well as mobile application testing and methodologies to accelerate time-to-market while prioritizing safety and effectiveness.
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