Jun 8 2012
MicroSun Technologies, an industry leader in customized alternative
power sources for the medical, commercial, military and government
markets, announced today that they have achieved ISO 13485:2003
certification, a globally recognized quality standard for the medical
device industry. MicroSun's scope of registration is specific to the
design and manufacture of rechargeable battery packs, chargers and
docking stations.
Chuck Pokonosky, Vice President of Sales & Marketing for MicroSun's
Commercial & Medical Business, commented on this achievement, "The ISO
13485 certification makes us stronger as a company and more competitive
in the marketplace because it builds confidence with our current and
future client base, by continuing to demonstrate our commitment to
taking our quality standards to a higher level."
The ISO 13485:2003 Standard contains 5 core requirements for medical
device manufacturing, installation and servicing:
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Implementation of a Quality Management System (QMS)
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Risk Management approach to medical product development and product
realization
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Validation of processes
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Compliance with statutory and regulatory requirements
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Effective product traceability and recall systems
Achieving this certification recognizes MicroSun's consistency in
linking business objectives with operating effectiveness. To achieve
this, our company had to demonstrate: effective implementation of
documentation and records management; top management's commitment to
their customers; establishment of clear policy; good planning,
implementation and resource management; and efficient process control,
measurement and analysis.
John Gatti, MicroSun's President and Chief Operating Officer, stated, "I
am proud of our team's achievement of this significant and
market-differentiating milestone. ISO 13485 is another example of
MicroSun's focus and commitment to excellence and performance for our
customers. Technology, innovation and performance form the cornerstone
of our strategy and focus and every associate throughout MicroSun is
dedicated to our customers' success."
Source: MicroSun Technologies