Impulse Dynamics
Impulse Dynamics Is Now Among the First US-based Manufacturers of Active Implantable Devices To Receive Certification
MARLTON, N.J., March 22, 2022 (GLOBE NEWSWIRE) -- 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’ EU notified body, has confirmed compliance of the company’s QMS with the MDR.
Dr. Deborah Morley, Vice President, Regulatory Affairs and Quality Assurance, said, "This very important milestone in the company’s 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."
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.
According to Impulse Dynamics’ CEO, Simos Kedikoglou, M.D., "Our ability to achieve certification of our QMS under the MDR affirms Impulse Dynamics’ 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."
About Impulse Dynamics
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers enhance the lives of people with HF by transforming how the condition is treated. The company has pioneered CCM therapy, which is delivered by the company’s Optimizer® system, a breakthrough, FDA-approved treatment verified to progress the quality of life for HF patients. CCM therapy is a safe and effective minimally invasive treatment option for many HF patients who otherwise have few effective options available to them. Visit www.ImpulseDynamics.com, or follow the company on LinkedIn, Twitter, and Facebook to learn more.
###
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml.globenewswire.com, please give your consent at the top of this page.
About Globenewswire
Subscribe to releases from Globenewswire
Subscribe to all the latest releases from Globenewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Globenewswire
TrueCommerce23.4.2024 19:11:45 CEST | Pressemeddelelse
TrueCommerce leverer globale e-fakturerings- og CTC-løsninger til virksomheder, der har udfordringer med overholdelse
TrueCommerce23.4.2024 12:01:08 CEST | Press release
TrueCommerce Delivers Global E-Invoicing and CTC Solution for Businesses Facing Compliance Challenges
Netbet Enterprises Limited23.4.2024 11:58:58 CEST | Press release
NetBet Casino joins forces with Wazdan
Netbet Enterprises Limited23.4.2024 11:58:58 CEST | Pressemeddelelse
NetBet Casino slår sig sammen med Wazdan
A/S Femern Landanlæg22.4.2024 10:15:20 CEST | Press release
GM Statement
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom