SAN FRANCISCO, Jan. 12 /PRNewswire/ -- Hiemstra Product Development, a premier product design and development company, announced today the debut of hiQual, its proprietary electronic quality management system (eQMS).
With the integration of hiQual, Hiemstra's development team can reduce risk and increase speed to market by constructing the necessary documentation required under ISO 13485:2003 and FDA 21 CFR 820 continuously throughout the product development cycle -- not afterwards. By doing it right the first time using hiQual, Hiemstra identifies risk up front and consistently, rapidly, and cost effectively delivers world-class medical products for its customers.
hiQual is Hiemstra's secure, fully validated, web-based quality management system that is accessible to clients 24/7. Hiemstra has integrated eQMS into all of its business processes, combining the creativity of a design firm, the controlled process of a medical device developer, and the agility of a start- up -- all under one roof.
"With hiQual, Hiemstra now offers our clients a complete documentation package beginning with design and development through V&V and manufacturing," noted Doug Hiemstra, President of Hiemstra. "For our customers that means no more missed steps along the way, no more costly iterations, no more backfilling, no more awkward moments during the critical final weeks when the pressure is on. And for funding partners that translates into projects that are delivered on time and within budget. hiQual makes complete real-time compliance throughout the development process a hassle free reality."
The benefits of hiQual include increased productivity and improved communication by providing engineers immediate access to highly organized project documentation. A robust reporting engine monitors all business processes behind the scenes and provides statistical analysis for V&V.
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