ExThera Medical Receives Certification for Medical Device Single Audit Program (MDSAP) and Recertification for International Organization for Standardization for Medical Devices (ISO 13485)

ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.

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Retrieved on: 
Tuesday, August 15, 2023
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Tags: 
Medical Devices, Infectious Diseases, Hospitals, Health, Oncology, Seraph, EUA, Medical device, Investigational device exemption, ANVISA, MHLW, ISO, COVID-19, NAE, MDSAP, Quality, Certification, MDD, Patient, Blood, European, HC, IDE, International Organization (journal), FDA, TGA, International Organization for Standardization, Medical device design, Pharmaceutical industry
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CALIFORNIA, UNITED STATES, NORTH AMERICA, EUROPEAN UNION, CANADA, AUSTRALIA, BRAZIL, JAPAN
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EXTHERA MEDICAL, EXTHERA MEDICAL CORPORATION, SERAPH 100 AND THE ONCOBIND PROCEDURE
Summary
Key Points: 
  • ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.
  • MDSAP certification confirms comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers looking to sell products within the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).
  • MDSAP certification has the added benefit of potentially expediting the timetable to commercialization within these participating geographies.
  • The internationally recognized ISO 13485 certification further confirms achievement of medical device manufacturer quality standards requirements necessary for global market entry.


ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements. MDSAP certification confirms comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers looking to sell products within the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA). MDSAP certification has the added benefit of potentially expediting the timetable to commercialization within these participating geographies. The internationally recognized ISO 13485 certification further confirms achievement of medical device manufacturer quality standards requirements necessary for global market entry.

“Receiving certification from these prestigious organizations demonstrates ExThera’s commitment to regulatory and quality standards that not only healthcare providers and patients require but is also an important milestone in our global development strategy,” said Sallie Coviello, Head of Quality and COO at ExThera. “With these approvals, ExThera is well-positioned to move forward with its plans toward global commercialization.”

As a leading company in extracorporeal therapies to remove pathogens and circulating tumor cells from the blood, achieving these regulatory and quality standards is paramount for success. “We continue to make rapid progress in our efforts to bring life-saving extracorporeal products to the market, with both our Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) for pathogen removal, and OncoBind™ Cancer Procedure,” said Robert Ward, Ph.D. (h)., NAE, the CEO & founder of ExThera Medical.

To date, the Seraph 100 has received both Medical Device Designation (MDD) CE Mark certification in the European Union, and Emergency Use Authorization (EUA) to treat COVID-19 in the United States and Canada. Earlier this month, ExThera also announced FDA approval of a recently submitted Investigational Device Exemption (IDE) application for its OncoBind™ Procedure to remove metastatic pancreatic cancer cells from blood.

ExThera’s commitment to quality is exemplified in these two recent certifications and demonstrates commitment to pursue global access for its Seraph 100 and OncoBind™ technologies: to provide benefit where there is significant unmet need and few existing treatment options.

About ExThera Medical Corporation

ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and other severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the US, the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100® attained CE Mark and is commercially available in the EU. The Seraph 100 has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the USA.

For more information visit the company’s website at www.extheramedical.com.

About Seraph 100 and the OncoBind Procedure

As a patient's blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph adds nothing to the bloodstream. It targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s proprietary adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.

For more news stories on the Seraph 100 and the OncoBind Procedure click here.

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