Medical Device Materials

Medical Device Materials

Comprehensively characterize polymers and medical device materials with Waters and TA Instruments robust analytical technologies and compliance-ready software solutions. Waters is committed to the development of innovative, safe, compliant, and effective medical devices by helping labs generate accurate materials profiles across the product lifecycle.

Comprehensively characterize polymers and medical device materials with Waters and TA Instruments robust analytical technologies and compliance-ready software solutions. Waters is committed to the development of innovative, safe, compliant, and effective medical devices by helping labs generate accurate materials profiles across the product lifecycle.
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Pacemaker implant x-ray in chest body
Pacemaker implant x-ray in chest body

Overview

Medical devices play a crucial role in the treatment, diagnosis, and care of patients, and medical device manufacturers must rigorously test the chemical structure and physical property materials to ensure both the devices and their packaging meet regulatory standards and performance criteria, guaranteeing their suitability for intended use.

Waters and TA Instruments combined instruments, software, consumables, and support enables robust workflows to streamline analytical testing and materials measurements – whether your lab is focused on chemical and materials property testing, extractables and leachables (E&L) studies, or durability assessment. Leveraging cutting-edge technological advancements and strategic partnerships with Waters, you can accelerate innovation and commercialization processes, simultaneously minimizing risks, cutting costs, and ensuring utmost patient safety.

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Applications

The physical and chemical characterization of materials is the first stage of biocompatibility testing, and involves the analysis of extractables and leachables (E&L), critical to patient safety. Learn about Waters high-performance LC and GC-MS technologies for separating, detecting, and identifying chemical compounds with these application notes.

The physical and chemical characterization of materials is the first stage of biocompatibility testing, and involves the analysis of extractables and leachables (E&L), critical to patient safety. Learn about Waters high-performance LC and GC-MS technologies for separating, detecting, and identifying chemical compounds with these application notes.

Application Notes

Material physical property or performance characteristics for safety, strength, and impact resistance helps in evaluating long-term stability and how materials will respond to specific processing and manufacturing conditions. Discover the impact Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Microcalorimetry, and Rheology can have on your analysis.

Material physical property or performance characteristics for safety, strength, and impact resistance helps in evaluating long-term stability and how materials will respond to specific processing and manufacturing conditions. Discover the impact Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Microcalorimetry, and Rheology can have on your analysis.

Application Notes

Medical devices must undergo extensive fatigue tests to confirm their reliability, predict their lifetime, and ensure the product complies with regulatory safety and performance standards. Learn how Waters technologies can streamline your testing process and help you leverage multi-specimen fatigue testing with these application notes.

Medical devices must undergo extensive fatigue tests to confirm their reliability, predict their lifetime, and ensure the product complies with regulatory safety and performance standards. Learn how Waters technologies can streamline your testing process and help you leverage multi-specimen fatigue testing with these application notes.

Application Notes

eBook: Medical Devices Regulatory Pathway

Whether increasing efficacy and reliability, reducing costs, or delivering personalized devices of the future, the medical device industry depends on materials science to deliver products that are fit for their intended use and meet regulatory and performance requirements. This eBook outlines the value of adopting a comprehensive approach to materials analysis in securing a first-to-market advantage.

Whether increasing efficacy and reliability, reducing costs, or delivering personalized devices of the future, the medical device industry depends on materials science to deliver products that are fit for their intended use and meet regulatory and performance requirements. This eBook outlines the value of adopting a comprehensive approach to materials analysis in securing a first-to-market advantage.
Download the ebook
A look inside the vien

Solutions

Waters and TA Instruments LC, GC-MS/MS, and measurement systems offer superior performance in separation and sensitivity for medical device materials characterization, identification, and quantitation.

Innovative technology, unmatched productivity, extraordinary possibilities

Innovative technology, unmatched productivity, extraordinary possibilities
Discovery X3 Differential Scanning Calorimeter

Obtain high quality heat flow data for up to three samples simultaneously with the Discovery X3 Differential Scanning Calorimeter that features a multi-sample cell to increase productivity on every level of your E&L material research. 

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

The most advanced rheometer for research and material development

The most advanced rheometer for research and material development
ARES-G2 Rheometer

Obtain the most accurate rheological data over a wide range of conditions with the ARES-G2, routinely used in R&D labs and manufacturing sites to gain detailed insights into a material’s micro-structure and relate it to the end-use properties.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

The world’s first benchtop high pressure TGA

The world’s first benchtop high pressure TGA
Discovery HP-TGA

Take high pressure TGA to a new level with the Discovery HP-TGA that offers a high balance resolution of better than 0.1 µg in an easy-to-use benchtop design for routine analysis.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

The next evolution in separation science is here

The next evolution in separation science is here
ACQUITY Premier System

Minimize metal-sensitive analyte loss and improve recovery with the ACQUITY Premier System for a step change in chromatographic performance, lab efficiency, and risk control.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Highly reliable, low complexity, accurate routine analysis for all

Highly reliable, low complexity, accurate routine analysis for all
Arc HPLC System

Replicate and improve the performance of your existing LC methods without compromising data quality with the Arc HPLC System that eliminates the burdens of older, less efficient LC systems.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

The ease of reversed-phase meets the power of normal-phase

The ease of reversed-phase meets the power of normal-phase
ACQUITY UPC2 System

Address your complex E&L separation challenges while delivering the reliability, robustness, sensitivity, and increased throughput of convergence chromatography techniques with the ACQUITY UPC2 System.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

No compromise GC-MS

No compromise GC-MS
Waters Atmospheric Pressure Gas Chromatography (APGC)
  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Whether you need to reach ultra-trace levels in complex samples for E&L, the Waters APGC source provides atmospheric pressure ionization for increased selectivity, sensitivity, and confidence in analyte identification – so your lab can overcome many of the typical limitations of vacuum-based systems. Waters APGC brings advanced MS technologies previously unavailable to GC users.

Absolute power to easily quantitate your most challenging compounds

Absolute power to easily quantitate your most challenging compounds
Xevo TQ Absolute

Reach lower limits of quantitation even for challenging negative ionizing compounds with the Xevo TQ Absolute, an incredibly compact tandem quadrupole mass spectrometer that delivers absolute performance.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Complete coverage for confident characterization

Complete coverage for confident characterization
Xevo G3 QTof

Maximize sample information for your analytes from detailed characterization to accurate quantitation with the Xevo G3 QTof, which enables complete confidence in your results.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Press on to bring the power of mass detection to your lab

Press on to bring the power of mass detection to your lab
ACQUITY QDa II Mass Detector

Reduce the risk of unexpected coelutions or constituent presence by routinely verifying trace chemicals with absolute certainty using the ACQUITY QDa II Mass Detector and increase the analytical value of every sample tested.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Waters software streamlines data acquisition, processing, and reporting medical device materials analysis results.

Simplify the screening workflow for extractables testing

Simplify the screening workflow for extractables testing
waters_connect Software Solutions

Perform structural elucidation of unknown compounds above the analytical evaluation threshold in less time with waters_connect Software Solutions, offering a simple workflow that includes scientific library creation, multivariate statistical analysis, and reporting.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Our full range of columns and consumables can be easily integrated into your chromatography and mass spec workflows.

Increase speed, sensitivity, and resolution without compromising data integrity

Increase speed, sensitivity, and resolution without compromising data integrity
ACQUITY UPLC Columns

Discover increases in LC efficiency, resolution, sensitivity, accuracy, speed, and reliability with ACQUITY sub-2-μm UPLC particle columns for your medical device materials analyses.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Achieve accurate results for your medical device materials analyses using streamlined Waters instrument services.

Optimize your instrument productivity

Optimize your instrument productivity
Instrument Services

Meet your lab’s evolving needs with Waters extensive portfolio of LC and LC-MS instrument support, qualification and services that offer quality, knowledge, and reliability for optimum lab productivity.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

Make science more accessible

Make science more accessible
Payment Solutions

Take advantage of the most advanced analytical technology available with innovative payment solutions from Waters Capital and bundle your complete laboratory solution in one easy monthly payment.

  • Extractables and Leachables Testing
  • Materials Property Testing
  • Durability Testing

The data speaks for itself

The data speaks for itself
Report examples for analysis information and target summary
Report examples for analysis information and target summary.
Cosmetic cream matrix-matched calibration curve for hydroquinone 0.01 to 5% w/w
Cosmetic cream matrix-matched calibration curve for hydroquinone 0.01 to 5% w/w.
Identified extractables in a low density polypropylene bottle (LDPE) hexane extract using ACQUITY UPC2
Identified extractables in a low density polypropylene bottle (LDPE) hexane extract using ACQUITY UPC2.
Peak identification and quantification
Peak identification and quantification.

Webinars and Resources

  • White Paper

Medical Devices: An Evolving Regulatory Landscape

Medical Devices: An Evolving Regulatory Landscape
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  • White Paper

Medical Device Material Development: Considerations to Minimize Extractables and Leachables 

Medical Device Material Development: Considerations to Minimize Extractables and Leachables 
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  • Webinar

Applying Data Integrity and 21CFR Part 11 on Complex Analytical Systems

Applying Data Integrity and 21CFR Part 11 on Complex Analytical Systems
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  • Webinar

Fatigue and Durability of Medical Devices

Fatigue and Durability of Medical Devices
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  • Webinar

Strategies for Screening of Non-volatile Extractable and Leachable Compounds

Strategies for Screening of Non-volatile Extractable and Leachable Compounds
Download

Related

Polymers
Today’s polymer manufacturers operate within an increasingly dynamic market space that is fueled by intense competition, complex regulatory considerations, and resurgence in polymer development.

Extractables & Leachables
Enable accurate, rapid, and cost-effective identification and quantification ​of extractables, leachables, and NIAS contaminants with Waters E&L analytical solutions.

Learn more about Medical Device Materials.

Learn more about Medical Device Materials.
Contact Sales
Pacemaker implant x-ray in chest body
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Medical devices must meet strict global standards to ensure safety, quality, and performance. The materials used such as polymers, metals, and coatings require thorough testing to verify their chemical composition, durability, and biocompatibility. Even minor impurities or residues can affect device reliability and patient safety. Compliance with regulations like ISO 10993, FDA 21 CFR Part 11, and EU MDR is critical for successful market approval.

Waters offers advanced materials testing solutions tailored for the medical device industry. Our analytical technologies including liquid chromatography, mass spectrometry, and infrared spectroscopy help manufacturers detect contaminants, monitor material degradation, and ensure consistent product quality. These solutions support extractables and leachables studies, failure analysis, and raw material selection to enhance device performance and lifespan.

By streamlining workflows and improving data accuracy, Waters helps manufacturers reduce testing time and costs while meeting regulatory requirements. With our expertise, companies can confidently navigate complex compliance landscapes and deliver safe, innovative medical devices to market faster.