[October 21, 2014] |
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Cambridge Design Partnership: Long Term Commitment to Quality Results in Rapid Accreditation to ISO 13485
CAMBRIDGE, England & PALO ALTO, Calif. --(Business Wire)--
Innovative technology and design consultancy Cambridge Design
Partnership has been awarded certification to ISO13485 and ISO9001, the
internationally recognised standards for quality management. As part of
a long term commitment to quality, the company was able to go through
the accreditation process rapidly to achieve certification in just six
months.
In the healthcare sector it is essential that the product development
process meets stringent regulatory requirements to ensure product safety
and efficacy. ISO13485 defines these requirements in Europe and
Cambridge Design Partnership has designed its quality management system
to be compliant with this standard as well as 21CFR820, the FDA's
quality system regulation in the US. Both these standards confirm that
the company can deliver regulatory compliant development programmes for
medical devices to healthcare companies in Europe and the US.
Working with an ISO13485 compliant partner like Cambridge Design
Partnership enables large pharmaceutical and medical device companies to
minimise the time and cost associated with integrating an external
development partner into their own quality management systems. This way
programmes can progress more rapidly and quality management occurs
seamlessly hroughout the project. These companies can be confident that
Cambridge Design Partnership's quality management team can provide full
technical and design history files for the complete development process
from concept insight to manufacture.
For high growth start-ups, Cambridge Design Partnership can provide an
outsourced product development service with an integrated quality
management programme, delivering the product design complete with all
the documentation needed for regulatory filings in both Europe and the
US.
Cambridge Design Partnership has many years' experience of developing
innovative medical devices for global companies, working with some of
the largest names in the industry. The ISO accreditation covers all of
CDP's processes, from concept development to verification & validation
testing, including stakeholder research, usability engineering,
mechanical, electronic and software engineering, as well as supply chain
& manufacturing development.
Commenting on the accreditation success, Partner Matt Schumann said,
"Major pharmaceutical and medtech clients constantly face the challenge
of bringing innovative new products to market in the minimum possible
time. Our ISO certification gives them the peace of mind to entrust us
with their most important product innovation programmes, confident that
our documentation can be used directly in regulatory submissions and
will withstand scrutiny from the regulatory authorities in both Europe
and the US."
------ENDS------
Cambridge Design Partnership LLP
Cambridge Design Partnership is a leading technology and product design
partner focused on helping its client's businesses grow. Some of the
world's largest companies trust CDP to develop their most important
innovations.
Cambridge Design Partnership specialises in the healthcare, consumer,
energy and industrial equipment markets and its multidisciplinary staff
have the expert knowledge to identify opportunities and solve the
challenges its clients face.
www.cambridge-design.co.uk
[email protected]
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