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 a Lead Scientist, progressed to a Manager in Regulatory Compliance and ending as a Senior Director Regulatory Compliance. She holds Master of Science degrees in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy and Health/HealthCare Administration/Management from Saint Joseph’s University respectively. She is certified Lean Six Sigma and holds a CPD from Wharton in Business Administration and Management. The GXP analysis she provided demonstrated the critical need for specific experts with the regulatory requirements for class ll medical devices in order to properly prepare and oversee the FDA 510k resubmission process. Her specific background in regulatory compliance of class II medical devices, along with her array of contacts and experience working with third party entities to maximize efficiencies in the design and regulatory processes, impressed upon RemSleep the immediate need in formally engaging her services. Judy Strzepek’s natural fit and addition to the team will help speed up and ensure a comprehensive and compliant 510K submission to FDA for our Patented DeltaWave Nasal Pillow Mask.
The GXP analysis also pointed specifically to the need of retaining a testing company that has this same particular finely tuned expertise in the testing and analysis of class II medical respiratory devices. After weeks of research and due diligence on numerous possible candidates in the regulatory testing field, the Company was led to a specific entity which has a state-of-the-art testing laboratory and whose methods and performance have been described as the "source of truth" in the regulatory testing arena. They are ISO/IEC 17025:2017 accredited and are fully equipped to support all of RemSleep’s material and product testing needs. This includes their expansive knowledge and functional experience pertaining to the ISO 18562 testing series, the ISO 10993 testing series, and regulatory device cleaning and disinfectant validation with an emphasis on what metrics and end points need to be set and met, specifically for FDA 510k medical class II respiratory devices regarding testing, evaluation, and analysis for FDA 510k submissions. After multiple conversations and detailed review of the GXP analysis and submission process to date, this company was retained by RemSleep and will be working hand in hand with Judy Strzepek.
Tom Wood, CEO and Product Designer for RemSleep commented further, “Throughout the challenges we have faced in this process, one thing has stood out: the need of seasoned experts for medical class II respiratory devices for testing, validation, compliance, and FDA 510k resubmission. We became painfully aware that not all labs, processes, or compliance directors are equal nor are their test methods or regulatory clearance processes necessarily ‘standard.’ We are fortunate that the recent challenges and outside expertise has led us to Judy and this third-party testing company, and both have the much-needed expertise that is required at this juncture for FDA success.” Wood continued, “Their combined expertise in medical respiratory device testing and analysis is second to none. We could not be in better hands to help navigate the idiosyncrasies in this complex and ever-evolving arena. It is an obvious regret we did not find both sooner in this process. Using their pre-evaluation of our existing trial data, submitted results, and further testing needed brought to our attention by the FDA, we feel we are now on the fast and narrow to achieve our end goal of FDA clearance for our patented DeltaWave Nasal Pillow Mask.”
RemSleep will update investors on new key timelines as soon as the new partners complete their final evaluation and testing scheduling can take place. Due to similar actions taken by competitors in the respiratory device industry surrounding confidentiality and competitive advantage, RemSleep will not be disclosing the name of the aforementioned third-party testing company.
About RemSleep Holdings Inc.
RemSleep Holdings Inc. is a medical device manufacturer dedicated to forever changing the level of treatment provided to obstructive Sleep Apnea patients. Our focus is primarily designing and manufacturing devices and products for the treatment of Sleep Apnea and other respiratory conditions. With over 30 years of collective experience in CPAP therapy, the RemSleep team has extensive knowledge and understanding of CPAP and the challenges of patient compliance. We diligently strive for our products to make the difference and improve the condition of those suffering from Sleep Apnea.
www.remsleep.com
Forward-Looking Statements
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Investor Relations Contact:
Preya Narain
347-837-0626
info@preya.co
