openPR Logo
Press release

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

12-16-2024 07:52 PM CET | Health & Medicine

Press release from: ABNewswire

STEMart Announces Balloon Catheter Testing Services to Ensure

STEMart introduces Balloon Catheter Testing Services for the development of safe and effective medical devices.
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing [https://www.ste-mart.com/medical-device-balloon-catheter-testing.htm] Services for the development of safe and effective medical devices. These reliable testing solutions will meet the evolving needs of the medical device industry and help manufacturers minimize the compliance risks.

Medical device testing is a crucial step in the development and commercialization of innovative medical devices. To ensure product safety and efficacy, comprehensive testing is required throughout the entire product lifecycle. STEMart's experienced team assists clients in meeting stringent regulatory standards, including ISO 10992, ISO 18562, FDA guidance, and ASTM standards. By providing a range of testing services for Class I, II, and III medical devices, STEMart helps clients navigate the complex regulatory landscape and bring their products to market with confidence.

Balloons and catheters, in particular, necessitate stringent testing to verify their intended use and labeling. STEMart offers advanced testing capabilities to assess critical parameters like balloon fatigue, inflation and deflation time, burst pressure, and balloon compliance. Its state-of-the-art facilities and adherence to FDA guidance documents and ISO standards guarantee accurate and reliable testing results, enabling clients to bring safe and effective balloon catheter products to market.

These comprehensive balloon catheter testing services can assess the performance and safety of medical devices. For example, the Burst Testing determines the maximum pressure a balloon catheter can withstand before rupturing. A controlled pressure increase is applied until the balloon fails, providing crucial data for safety assessments. Additionally, the Fatigue Testing evaluates the balloon's ability to be safely cycled through a defined number of inflations to rated pressure, meeting the testing requirements of ISO 10555 or FDA guidelines.

To ensure the long-term reliability and performance of balloon catheters, additional testing is necessary. Compliance testing measures the balloon's diameter at various pressure levels to assess its ability to expand and contract as needed. Finally, inflation/deflation testing determines the time required for the balloon to fully inflate and deflate, which is essential for efficient and effective clinical procedures. These tests, often conducted using an automatic inflation/deflation system, help ensure that balloon catheters meet the stringent requirements.

With extensive expertise in medical device balloon catheter testing, STEMart can provide comprehensive services to help manufacturers meet regulatory objectives and minimize compliance risks. STEMart's experienced team of engineers and technicians leverages state-of-the-art equipment and rigorous testing protocols to ensure medical devices meet the highest quality standards and regulatory requirements. To find out more about other medical device testing solutions, or to consult with the experts at STEMart, please visit https://www.ste-mart.com/medical-device-balloon-catheter-testing.htm.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.

Media Contact
Company Name: STEMart
Contact Person: Staci Horme
Email:Send Email [https://www.abnewswire.com/email_contact_us.php?pr=stemart-announces-balloon-catheter-testing-services-to-ensure-medical-device-safety-and-regulatory-compliance]
Country: United States
Website: https://www.ste-mart.com/



This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance here

News-ID: 3789357 • Views:

More Releases from ABNewswire

Leavitt Peak Press Announces the Release of the Guardians: Paporia Two by F. Thomas Jones - A Bold New Chapter in an Epic Interstellar Saga
Leavitt Peak Press Announces the Release of the Guardians: Paporia Two by F. Tho …
Leavitt Peak Press is proud to announce the release of The Guardians: Paporia Two, the action-packed sequel to The Guardians: Escape from Tirgonia by military veteran and author F. Thomas Jones. This thrilling continuation of the Guardians saga dives deeper into a galactic conflict that pits courage, loyalty, and wisdom against overwhelming odds. Now in the second year of war with the ruthless Tirogian Empire, The Guardians face their greatest challenge
Jiaropack Expands Global Footprint and U.S. Manufacturing to Strengthen Supply Chain and Delivery Network
Jiaropack Expands Global Footprint and U.S. Manufacturing to Strengthen Supply C …
Image: https://www.abnewswire.com/upload/2025/10/e8885cfe8ab28873224866f01a36a3fa.jpg California, USA - Jiaropack, a brand of Global Store Supply, Inc., a global leader in packaging, industrial, and shipping materials, today announced a major expansion of its U.S. manufacturing and logistics network to further enhance supply chain stability and nationwide delivery efficiency, providing faster and more reliable products and services to customers worldwide. To enhance supply chain security and consistent product delivery, Jiaropack has recently purchased several Texas-based plastic product
Clostridioides Difficile Infection Market Size in the 7MM was ~USD 500 million in 2024 and It is expected to increase by 2034, estimates DelveInsight
Clostridioides Difficile Infection Market Size in the 7MM was ~USD 500 million i …
DelveInsight's "Clostridioides Difficile Infection Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Clostridioides Difficile Infection, historical and forecasted epidemiology as well as the Clostridioides Difficile Infection therapeutics market trends in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. Discover Key Insights into the Clostridioides Difficile Infection Market with DelveInsight's In-Depth Report @ Clostridioides Difficile Infection Treatment Market Size
Triple Negative Breast Cancer Market Set for Robust Growth Through 2034Innovative therapies and rising incidence drive steady expansion across the US, Europe, and Japan
Triple Negative Breast Cancer Market Set for Robust Growth Through 2034Innovativ …
Driven by rise of immunotherapies, antibody-drug conjugates, and precision-targeted approaches, TNBC market is projected to expand from USD 4.7 billion in 2025 to USD 7.1 billion by 2034, marking a CAGR of 4.7% across the 7MM. Leading players like AstraZeneca, Pfizer, Gilead Sciences, BioNTech, Astellas Pharma are at forefront, advancing next-generation therapies such as ADC platforms, checkpoint inhibitors, and novel vaccines that aim to improve survival outcomes and redefine patient

All 5 Releases


More Releases for STEMart

STEMart Launches Catheter Dynamics Performance Testing to Elevate Medical Device …
STEMart announces a comprehensive suite of Catheter Dynamics Performance Testing services for medical device manufacturers. STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce a comprehensive suite of Catheter Dynamics Performance Testing [https://www.ste-mart.com/medical-device-catheter-dynamics-performance-testing.htm] services for medical device manufacturers to identify potential design flaws and optimize catheter performance, ensuring the safety and efficacy of their catheter-based devices. Catheter Dynamics Performance Testing is a critical
STEMart Introduces Advanced Accelerated Aging Testing Services for Medical Devic …
STEMart launches new Accelerated Aging Testing Services for medical device manufacturers. STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its new Accelerated Aging Testing [https://www.ste-mart.com/accelerate-aging-testing.htm] Services for medical device manufacturers to ensure the long-term reliability and safety of their products. The Accelerated Aging Testing utilizes high temperatures for a period of time to simulate the effects of real-time aging, artificially accelerating
STEMart Announces Comprehensive Real-Time Aging Testing Services for Medical Dev …
STEMart announces the launch of its new Real-time Aging Testing services. STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce the launch of its new Real-time Aging Testing [https://www.ste-mart.com/real-time-aging-testing.htm] services to accurately assess the long-term performance and integrity of medical device packaging under real-world storage conditions. These services offer manufacturers a reliable and accurate method for determining product stability and ensuring consumer
STEMart Strengthens Medical Device Development with Advanced Package Material Te …
STEMart announces the launch of its new Package Material Testing solutions for medical device professionals. STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Package Material Testing [https://www.ste-mart.com/package-material-testing.htm] solutions for medical device professionals. This expanded service line provides manufacturers with a robust suite of tests to ensure the integrity and suitability of packaging materials throughout the medical
STEMart Launches Comprehensive Medical Device Packaging Solutions
STEMart announces the launch of its Packaging Solutions for the pharmaceutical and medical device industries. STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its comprehensive suite of Packaging Solutions [https://www.ste-mart.com/medical-device-packaging-solutions.htm] to meet the unique needs of the pharmaceutical and medical device industries. These services are designed to ensure the quality, sterility, and regulatory compliance of medical devices throughout their lifecycle. Packaging
STEMart Announces Pilot Production Services for Medical Devices
STEMart launches its new Pilot Production Services for the medical device industry. STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Pilot Production Services [https://www.ste-mart.com/pilot-production-of-medical-devices.htm] for the medical device industry. These services allow manufacturers to test and refine their products prior to full-scale production, streamlining the development process of new medical devices and minimizing risk to save