Reduce Risk, Achieve Compliance and Accelerate Time to Market with hiQual and Hiemstra...

Reduce Risk, Achieve Compliance and Accelerate Time to Market with hiQual and
Hiemstra Product Development
hiQual eQMS guides efficient product development process

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.
With better and more consistent definition, Hiemstra eliminates
uncertainty about the steps required in the development process. hiQual
reduces risk by preventing the omission of critical design activities,
deliverables and analyses. hiQual dramatically reduces the time and expense
involved in creating, approving and storing DHF documentation, further
reducing the time required to prepare regulatory submissions.
About Hiemstra:
Hiemstra is an innovative product design and development company serving
the life sciences industry. The firm is built on its unparalleled integration
of industrial and mechanical design, with a unique focus on usability, quality
and rapid commercialization.
Hiemstra's veteran team's experience spans a range of engineering acumen
and medical applications. Their clients include start-ups to Fortune 500
companies. Hiemstra serves medical technology companies from early-stage
ideation to final assembly, or any step along the way. A description of
services can be found at http://www.hiemstra.com.
SOURCE Hiemstra Product Development, LLC

Doug Hiemstra of Hiemstra Product Development, LLC, +1-415-495-6441, ext. 109,
1-888-400-3374, dmh@hiemstra.com