The only efficient, cost-effective, and
compliant way for U.S. medical device
companies to get their products to
market in the United States and abroad
is to involve regulatory affairs in every
aspect of a medical device’s life cycle.
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within the FDA gradually is changing. In fact, once the present
510(k) issues are sorted out in the United States, it’s very likely
that the FDA will start scrutinizing post-market surveillance as
well. The FDA already has started putting the framework together
for new post-market surveillance requirements, which means that
medical device companies should expect to soon feel the pressure
to gather better information about their device’s total product life
cycle and to implement more robust risk management and change
To Protect and Serve
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Regulatory professionals often are referred to as“police” in today’s global medical device marketplace, and much like local
law enforcement, regulatory affairs’ job is two-fold: Protect the
medical device manufacturer from getting into trouble with the
authorities regulating them; and serve the needs of all stakeholders by helping to ensure that the company gets safe, reliable
products to market efficiently and cost-effectively—without any
barriers to clearance.
manufacturing solutions in MPO's
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medical device OEMs is a must for all
suppliers to be seen and recognized.
To adequately do their job, RA must be included in the conversations that take place at each stage of the device’s life cycle. By
involving RA in every key device-related meeting and decision;
allowing them to review designs early; and collaborating with RA
on test plans, reports, and timelines, medical device manufacturers will be better able to succeed with their innovations and with
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For medical device companies that do not have an in-house
regulatory affairs group, it’s essential to work with a company
that has extensive RA expertise, direct communication with the
FDA, and can provide accurate and prompt clarification on PMA
and 510(k) submissions. v
Ad Closing Date:
December 3, 2014
Contact Howard Revitch at
201-880-2243 • firstname.lastname@example.org
Kellen Hills is the senior regulatory consultant for Orchid Orthopedic
Solutions. In addition to designing and manufacturing implants and
instruments for the orthopedic, dental and cardiovascular markets,
Orchid provides regulatory expertise, document preparation, and submission strategies to help medical device companies ensure regulatory
compliance from concept to post-market surveillance.