RedHawk Partners With Pelican Engineering LLC for GMP Manufacturing Oversight
February 28, 2020 | PR NewswireEstimated reading time: 2 minutes
RedHawk Holdings Corp., a diversified holding company engaged in sales and distribution of medical devices, branded generic pharmaceutical drugs, commercial real estate investment and leasing, point of entry full-body security systems, and specialized financial services, announced today that RedHawk Research & Development LLC, a wholly-owned subsidiary of the Company, has agreed to partner with Louisiana-based Pelican Engineering LLC ("Pelican") for the supervision of the Company's quality assurance and future research and development programs.
Pelican is a full-service electronics engineering design firm that provides engineering services and component manufacturing in all aspects of the electrical, electronics, and computer engineering disciplines. Primarily focused on embedded printed circuit board hardware and software development, Pelican is capable of in-house engineering, design, manufacturing, and turn-key delivery of high-quality embedded systems.
Pelican was instrumental in the redesign of the SANDD Pro™ as well as the new printed circuit boards used in the SANDD mini – HP™ and the SANDD mini – FR™. Separately, Pelican is also expected to lead the development and redesign of "Centri", the Company's controlled entry security system, a unique, closed cabinet, nominal dose transmission full-body x-ray scanner.
In June 2019, the Company announced the transition and ongoing maintenance of its current FDA-approved quality management system to the higher and more stringent international medical device standard, ISO 13485:2016. The Company believes it is now near completion of this previously announced quality management transition and has now partnered with Pelican to develop and supervise the quality assurances testing believed necessary to maintain adherence to the stringent standards of ISO 13485:2016.
ISO 13485:2016 specifies global requirements for a quality management system where an organization must demonstrate its ability, and the ability of its suppliers, to provide medical devices and related services that consistently meet customer and applicable international regulatory requirements. ISO 13485 was specifically developed with the objective of harmonizing medical device regulatory requirements for quality management systems in major markets around the world including the United States, Europe, Canada, Japan and Australia. ISO 13485 meets, or exceeds, all U.S. Food and Drug Administration Quality System Regulations Standard 21 CFR 820 which was established in 1978 to outline Current Good Manufacturing Practices (GMP) in the United States.
Commenting on the partnership with Pelican, G. Darcy Klug, RedHawk's Chairman and Interim Chief Executive Officer, said "We believe the previously announced partnership with the CKRX Enterprise sales organization positions us well for the commercial launch of our SANDD™ line of needle incineration products.Our next marketing focus is the consumer launch of the SANDD™ line of needle incineration devices. To properly position RedHawk for the consumer market, we believe we need to obtain Durable Medical Equipment ("DME") Accreditation of our quality assurance program. The transition of our quality assurance program to ISO 13485:2016 and the completion of the quality assurance partnership with Pelican is the next step in preparing for DME Accreditation."
"DME Accreditation is necessary for RedHawk to obtain a DME supplier license," continued Mr. Klug. "With Pelican's support, we believe that we are now positioned to seek the necessary DME Accreditation approvals. With DME Accreditation, we anticipate our customers will be eligible to receive Medicare, Medicaid or insurance company reimbursement for the purchase of our SANDD™ line of needle incineration devices. Obtaining these approvals would be a major milestone on the path for RedHawk to continue executing on its business model."
Suggested Items
Real Time with... IPC APEX EXPO 2024: MYCRONIC's Evolution and New Solutions
04/17/2024 | Real Time with...IPC APEX EXPOHenry Crandall interviews Kevin Clue, the vice president of global sales for MYCRONIC's High Flex division. They discuss the company's evolution, emphasizing its strong customer relationships and its role as a versatile, turnkey solution provider. Kevin unveils new solutions launched at IPC APEX EXPO, including an AI-integrated inspection system and the A40 pick-and-place platform. The conversation also touches on the increased use of AI and deep learning.
Australian Flow Batteries and The SCHMID Group Announce Groundbreaking Memorandum of Understanding
04/17/2024 | SCHMID GroupAustralian Flow Batteries Pty Ltd (AFB), a leader in innovative energy solutions and economical, safe, and reliable power storage, and SCHMID Energy Systems GmbH a company of the German SCHMID Group, a global technology leader with a rich history in delivering innovative solutions across multiple industries including Electronics, Renewables, and Energy Storage sectors, are thrilled to announce the signing of a Memorandum of Understanding (MoU)
Ansys Joins BAE Systems’ Mission Advantage Program to Advance Digital Engineering Across US Department of Defense
04/16/2024 | ANSYSAnsys announced it is working with BAE Systems, Inc., to accelerate the adoption of digital engineering and MBSE across the Department of Defense (DoD).
Designing Electronics for High Thermal Loads
04/16/2024 | Akber Roy, Rush PCB Inc.Developing proactive thermal management strategies is important in the early stages of the PCB design cycle to minimize costly redesign iterations. Here, I delve into key aspects of electronic design that hold particular relevance for managing heat in electronic systems. Each of these considerations plays a pivotal role in enhancing the reliability and performance of the overall system.
SIA Applauds CHIPS Act Incentives for Samsung Manufacturing Projects in Texas
04/16/2024 | SIAThe Semiconductor Industry Association (SIA) released the following statement from SIA President and CEO John Neuffer applauding semiconductor manufacturing incentives announced by the U.S. Department of Commerce and Samsung.