AUSTIN, Texas, Feb. 10, 2021 /PRNewswire/ — Technology and consulting firm, Headspring, received FDA approval of their first product built for the Plasma industry. Developed in partnership with the Protein Plasma Therapeutics Association (PPTA), this new National Donor Deferral Registry & Cross Donation Check System (NDDR & CDCS) protects both patients, donors and collectors. It gives collectors quick access to a national registry of donor information and enables near real-time updates.
“PPTA worked enthusiastically with Headspring to build the next generation of NDDR & CDCS, applying state-of-the art technology that supports our industry’s deep commitment to the highest standards of donor health and safety for the future,” said Amy Efantis, President and CEO of PPTA.
Headspring’s CEO, Dustin Wells, added, “While our development processes had the right quality from the start, we were able to adapt our Program Management and Quality practices to meet rigorous medical device standards—on our first submission and within a short timeline.”
The regulatory compliance and quality firm, Validant, consulted with Headspring on this process. Validant’s CEO Brian Burns remarked, “It was a pleasure to work with such a high-quality software team. Their practices are well aligned to meet the standards expected in the Plasma industry.”
With the NDDR & CDCS, now poised for adoption by the Plasma industry, Wells celebrates the team effort: “This FDA approval is a testament of our commitment to building quality products, and our partners, Validant, and PPTA all helped make it possible.”
Headspring is a technology consulting firm transforming organizations with cloud-first solutions, from application development to architectural strategy to legacy system transformation. Headspring’s teams are motivated daily by the core belief that great software has the power to transform organizations and lives.
Validant is a provider of Regulatory and Quality consulting to the global Healthcare industry. Services include consulting, compliance audits, and full-cycle development of product submissions. Validant is an expert in guiding healthcare providers, pharmaceutical companies, and medical device manufacturers in bringing their products to market.
The Plasma Protein Therapeutics Association (PPTA), a global industry trade association, represents private sector manufacturers of plasma-derived and recombinant analog therapies, and the collectors of source plasma. PPTA administers standards and programs to help ensure the quality and safety of plasma protein therapies, donors, and patients.
Source: PR Newswire
NOTE: Donors with questions about NDDR should visit https://www.pptaglobal.org/safety-quality/national-donor-deferral-registry. Headspring Healthcare can only confirm that a donor has been deferred, and by whom. We have no further information and are not authorized to alter NDDR records.