Former FDA Regional Director Joins Medical Device Contract Design Company
Summa Design, a contract design and development company focused on the medical device industry, announced today that Dudley Harris, a former Regional Director for the FDA, has joined Summa Design as Director of Regulatory Affairs and Quality Systems.
Montrose, CO (PRWEB) April 18, 2005 -- Summa Design, a contract design and
development company focused on the medical device industry, announced today that
Dudley Harris, a former Regional Director for the FDA, has joined Summa Design
as Director of Regulatory Affairs and Quality Systems.
Mr. Harris will
be working with Summa Design’s client companies offering services ranging from
FDA and international regulatory compliance audits to 510(k) submission
coauthoring and review. He will serve in an advisory role on most projects to
ensure a smooth transition of the client’s product through the FDA approval
process.
Jon Ferris, President & CEO of Summa Design, stated, “As a
leader in the medical device outsourcing industry, we are constantly striving to
be responsive to the needs of our clients and reduce overall time-to-market. We
are excited that Dudley’s skills and experience complement our existing
expertise so well.” Mr. Ferris went on to explain, “We have a team of
senior-level engineers and managers and have developed an efficient engineering
process to get products realized quickly. We can now carry that efficiency well
beyond design and development into the regulatory approval process.” He added,
“Having a former Regional Director on staff to share his 30 years of insider’s
knowledge of the FDA will benefit virtually all of our clients. Our reputation
as a first-class outsourcing firm is strengthened today as we welcome him to our
team. Our broad range of services continues to clearly differentiate us from the
competition.”
The Company
Summa Design is a global, privately-held,
medical device contract design company based in Colorado. Their client list
includes Fortune 500 medical device companies, as well as small start-ups. Summa
Design provides an unparalleled range of services in the industry, including
engineering design and development services, marketing, sales, distribution, and
FDA and international regulatory consulting. Summa Design was the first contract
design firm to offer an industry-leading “VC Partner Program©”, which promotes
relationships with venture capital companies and allows Summa Design to
introduce start-up clients to funding sources. For more information, please
visit www.summa-design.com.
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Source : http://www.prweb.com/releases/2005/4/prweb229882.htm