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RemSleep Holdings Inc. Engages New Senior Director for Regulatory Compliance and New Regulatory Testing Company
RemSleep Holdings Inc. Engages New Senior Director for Regulatory Compliance and New Regulatory Testing Company.
About this update from Remsleep Holdings, Inc.
[{"type":"text","content":"\n Tampa, FL, July 22, 2022 (GLOBE NEWSWIRE) -- RemSleep Holdings Inc. (OTC Pink: RMSL), a medical device manufacturer dedicated to forever improving the level of treatment provided to obstructive Sleep Apnea patients, announces the company has formally retained a new Senior Director for Regulatory Compliance and Regulatory submissions to gain FDA clearance to market the company’s medical device respiratory products. In addition, a new Regulatory Testing Company has been engaged.  Both will work together in unison to oversee the company through testing and final submission for our patented DeltaWave Nasal Pillow Mask. Like many others, RemSleep has faced numerous challenges over the last two years during the Covid Pandemic. The company has experienced a number of major milestones and setbacks while facing a learning curve throughout the process. One of the critical lessons has been the need for infrastructure around the organization that possesses detailed understanding of the regulatory complexities and testing requirements specific to demonstrating the safety and effectiveness of our class II respiratory medical devices, such as the DeltaWave mask. One setback the company had was a result of the lack of critical expertise. This information was previously detailed in a letter by certified toxicologist, Dr. Joe Nieusma, and was included in a recent Form 8K. This issue has since been resolved, but analysis conducted demonstrated to RemSleep the importance of aligning its infrastructure specifically around the expertise of class ll respiratory medical devices as it pertains to both FDA 510k testing and submission. Given the new classification and definitive guidelines set forth by the FDA, Dr. Joe Nieusma found and recommended Judy Strzepek to the company, and helped facilitate a GXP analysis of previous attempts to submit testing data to the FDA for a 510K clearance. With over twenty years of director level experience with a Fortune 50 company regulated by FDA, Judy Strzepek’s career has been focused in the healthcare industry working on GXP compliance including the design control, quality assurance, regulatory affairs, and medical device regulatory clearance for medical devices and related devices. She held multiple Quality Systems roles and demonstrating increasing levels of responsibilities that began as ...