RICHMOND, Va., Sept. 11, 2020 (GLOBE NEWSWIRE) -- via NetworkWire -- Blackbriar Regulatory Services (BRS), a firm specializing in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market, has entered into medical device manufacturing, producing face masks in response to COVID-19.
“When BRS was created earlier this year, medical device manufacturing was part of our predetermined business strategy,” said Russ Rogers, CEO of BRS. “With the COVID-19 outbreak, it made sense to accelerate our plan to enter into this market segment, and we had the resources to quickly ramp up our manufacturing capabilities to help U.S. frontline workers with the domestic face mask shortage. Because this aligns so well with our strategy, we already have in place the management team with experience in the medical device space, as well as the requisite quality systems, facilities, and non-woven materials processing background to do this right and get it done quickly. It’s really a perfect fit for us and natural progression.”
In addition, BRS provides regulatory and scientific services, including U.S. FDA Premarket Tobacco Applications (PMTA) and CBD clean room manufacturing. As a result, the company has extensive manufacturing experience working within highly regulated industries and understands FDA product requirements. BRS also operates in an FDA medical device registered facility.
Adult and child masks produced by BRS have proven efficacy to reduce particles and bacteria by more than 95% at competitive prices and lead times due to being made right here in the U.S. The company is able to utilize meltblown filter media produced in the United States due to a strategic relationship that it has built to ensure long-term supply of this material that is in very short supply. Meltblown non-woven micro and nano-fiber material makes up the functional filtration layer of 3-ply masks and is fabricated by melting polymer and extruding it through small nozzles surrounded by high-speed blowing gas. When used in high-quality masks, this material must also be statically charged to improve filtration efficiency. BRS has also invested in specialized quality testing equipment to certify the quality and effectiveness of each batch of mask production.
“We are investing in face mask production for the long term,” said Rogers. “Customers can expect the highest quality USA made product and a swift delivery, and we look forward to manufacturing additional medical devices in the future. BRS has the bandwidth to exponentially expand current face mask production based on customer needs and demand.”
“We are very excited to partner with the team at BRS to support the demand challenges facing the healthcare supply chain,” said Jay Stotlar, President at Hutchins & Hutchins, one of BRS’ first customers for its face mask production. “Our clients in the Veterans Health Administration will be among the first to receive the newly U.S.-manufactured masks.”
About Blackbriar Regulatory Services
Since its inception, BRS has perfected processes in cost efficient manufacturing, analytical testing, regulatory compliance audits and filings, rigorous project management, packaging design, and product stewardship for international customers from the United States, Europe, and Asia. BRS prides itself on speed and flexibility, while never compromising quality or their customers’ confidential information.
Learn more at bb-rs.com.
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