ORANGEBURG, NY, September 24, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, has received the MDSAP Certification. Following successful audits, DEKRA Certification B.V., issued the certificates on Monday, September 23rd.
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Impulse Dynamics’ MDSAP Certification meets the regulatory requirements in all five countries currently participating: Australia, Brazil, Canada, Japan and the United States.
“Obtaining MDSAP certification is an important milestone for the company and recognizes the highly developed, and efficient Quality Management Systems in place at Impulse Dynamics” said Impulse’s Vice President of Regulatory Affairs and Quality Assurance, Dr. Deborah Morley. MDSAP certification simplifies Impulse Dynamics’ regulatory activities and enables the company to focus on making CCM Therapy available to all eligible patients globally.“
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 3,500 patients and is currently available in the US, Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 papers in leading medical journals.
Impulse Dynamics is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit www.impulse-dynamics.com.
Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962