IMPULSE DYNAMICS’ QUALITY MANAGEMENT SYSTEM RECEIVES CERTIFICATION UNDER EUROPEAN UNION MEDICAL DEVICE REGULATION

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.”