{"id":240899,"date":"2022-03-22T09:22:37","date_gmt":"2022-03-22T13:22:37","guid":{"rendered":"https:\/\/impulse-dynamics.com\/?p=240899"},"modified":"2024-01-17T04:28:24","modified_gmt":"2024-01-17T09:28:24","slug":"impulse-dynamics-quality-management-system-receives-certification-under-european-union-medical-device-regulation","status":"publish","type":"post","link":"https:\/\/impulse-dynamics.com\/global\/impulse-dynamics-quality-management-system-receives-certification-under-european-union-medical-device-regulation\/","title":{"rendered":"Impulse Dynamics’ Quality Management System Receives Certification Under European Union Medical Device Regulation"},"content":{"rendered":"

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PRESS\u00a0
RELEASE<\/h2>\n

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Impulse Dynamics Is Now Among the First US-based Manufacturers of Active Implantable Devices To Receive Certification<\/em><\/strong><\/h2>\n

MARLTON, N.J., March 22, 2022 <\/strong>(GLOBE NEWSWIRE) \u2014 Impulse Dynamics, a company dedicated to innovative treatments for chronic heart failure, is pleased to announce that it has successfully completed the requirements for certification of its quality management system (QMS) under the new Medical Device Regulation (MDR) (EU 2017\/745 ) now in force in the European Union (EU). With the award of a full quality assurance certificate under the MDR to Impulse Dynamics in February 2022, DEKRA B.V., Impulse Dynamics\u2019 EU notified body, has confirmed compliance of the company\u2019s QMS with the MDR.<\/p>\n

Dr. Deborah Morley, Vice President, Regulatory Affairs and Quality Assurance, said, \u201cThis very important milestone in the company\u2019s overall development clearly recognizes the tremendous efforts of the Impulse Dynamics team to maintain a state of the art QMS. Certification of the QMS under the MDR allows us to proceed with the development and approval of our new products in accordance with current EU regulations ensuring both safety and performance of devices for their intended clinical application. This allows Impulse to continue on its stated goal to provide CCM therapy to all heart failure patients in need in Europe and other geographies. This is a company-wide achievement, and I am especially proud of the Quality Assurance team who managed all of the activities required to establish compliance with the new regulation.\u201d<\/p>\n

The Medical Device Regulation (EU 2017\/45) went into effect in May of 2021 for all manufacturers, distributors, and users of medical devices in the EU, replacing the prior Medical Device Directive and Active Implantable Medical Device Directive. In comparison to the previous directives, the MDR requires more stringent documentation of the technical aspects of a medical device, enhanced clinical evidence requirements, detailed documentation of post-market surveillance activities, and a more comprehensive QMS for medical device manufacturers like Impulse Dynamics. As such, most companies selling products in the EU have had to make significant improvements to documentation, technical testing, and clinical evaluation of their medical devices in order to comply with the new MDR. Notably, given the amount of work required, Impulse Dynamics is one of the first manufacturers of an active implantable device to receive QMS certification under the MDR in the United States.<\/p>\n

According to Impulse Dynamics\u2019 CEO, Simos Kedikoglou, M.D., \u201cOur ability to achieve certification of our QMS under the MDR affirms Impulse Dynamics\u2019 position at the leading edge of medical device design, development, and manufacturing. This, in turn, allows us to adhere to the most important goal of making the patient our first priority by providing medical devices of the highest quality. MDR certification opens the door for Impulse Dynamics to proceed with its plans for new product development and to launch them without delay.\u201d<\/p>\n

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About the Optimizer and CCM\u00ae<\/sup><\/span><\/em><\/strong> Therapy<\/strong>
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve systolic contraction of the heart. The Optimizer Smart System was granted \u201cBreakthrough Device\u201d designation by the U.S. Food and Drug Administration, and it is the first and only CCM device approved in the U.S. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart initiates contractions. In doing so, it strengthens and helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, the results of which have been published in over 80 articles appearing in leading medical journals. Studies have shown CCM therapy to sustainably improve 6-minute hall walk distance, quality of life, and functional status among patients who are candidates for the device. The Optimizer Smart has been implanted in over 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India, and more than 40 other countries around the world.<\/p>\n

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About Impulse Dynamics<\/strong>
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM<\/em><\/strong>\u00ae<\/sup><\/span> therapy, which is delivered by the company\u2019s Optimizer system, a breakthrough, FDA-approved treatment verified to improve the quality of life for heart failure patients.[1]<\/a> CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few alternatives available to them.1<\/sup> \u00a0To learn more, visit www.ImpulseDynamics.com<\/a>, or follow the company on social media at LinkedIn<\/a>, Twitter<\/a>, and Facebook<\/a>. [1]<\/a> https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5494150\/<\/a><\/p>\n

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\nImpulse Dynamics (USA), Inc.<\/strong>
50 Lake Center Executive Park, 401 Route 73 N, \u2010 Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642\u20109933
www.impulse\u2010dynamics.com<\/p>\n

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INVESTOR<\/strong> CONTACT<\/strong>:<\/p>\n

Harriss Currie
CFO
Impulse Dynamics
hcurrie@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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MEDIA CONTACT: <\/strong>\u00a0<\/strong><\/p>\n

Rex Richmond
Director of Media Relations
Impulse Dynamics
rrichmond@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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PUBLIC RELATIONS: <\/strong>\u00a0<\/strong><\/p>\n

Ian Segal
Manager, Public Relations
Impulse Dynamics
isegal@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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