Dallas, TX, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Spark Biomedical, a leading developer of wearable neurostimulation devices, proudly announces the recent achievement of ISO 13485:2016 and MDSAP Quality Certifications, marking a significant milestone in its commitment to quality and safety in healthcare. With these certifications, Spark is poised to extend its transformative neurostimulation solutions globally.
“These certifications,” Daniel Powell, CEO of Spark Biomedical comments, “are a testament to Spark’s dedication to quality and diligence throughout all aspects of the business. Furthermore, this enables our international expansion, with Canada and Australia targeted in Q4 of 2024, followed by other key markets throughout 2025.”
The ISO 13485:2016 and MDSAP certifications, issued to Spark Biomedical by DEKRA, recognize the company as both a developer and manufacture. This acknowledgement confirms Spark’s adherence to quality standards across the entire lifecycle of its product and enhances its ability to deliver life-changing technologies to those in need worldwide.
Brent Croft, VP of Quality at Spark, added, "From the very beginning, our focus has been on quality. These new certifications exhibit our continuing dedication to quality and our capability to deliver safe and effective solutions that meet rigorous international standards.”
About Spark Biomedical
Spark Biomedical, Inc. is a leading U.S.-based medical device developer, committed to unlocking the potential of bioelectronic medicine and bringing to market novel wearable neurostimulation treatment options in behavioral health, women’s health, hemostasis, pediatrics, and chronic pain.
Spark leverages its neuroscience and engineering expertise to empower healthcare providers and researchers with innovative, evidence-based tools designed to address complex care situations which exceed the capabilities of existing treatment options. Spark has received funding from federal institutions, such as the NIH and DoD, and continues to partner with private and academic institutions. Spark Biomedical is empowering a better way forward for the future of patient care and medical technology. For more information, visit sparkbiomedical.com
For more information, please contact Udim Obot at udim.obot@sparkbiomedical.com
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