510(k) Approval Problems? QPC Services Can Help.
New FDA submission solutions get rid of the headaches, time and cost associated with 510(k) premarket notification approvals.
QPC Services is an FDA Approval Consulting firm with Certified 510(k) Consultants and Quality Managm
510k Approval Consulting, FDA 510(k) Consultants, FDA Premarket Notification Process - QPC Services
Headquartered in Mesa AZ with offices across the US, QPC Services helps executives and upper management – from Fortune 500 medical device companies to private business owners – that need to get their FDA, medical and pharmaceutical regulatory challenges and related business problems identified, under control and permanently behind them.
President, Founder and industry veteran Jim Dunning leads QPC Services. He’s senior member of the American Society for Quality (ASQ), a member of the Regulatory Affairs Professional Society (RAPS) and a member of the International Society for Pharmaceutical Engineering (ISPE). Jim has recently increased focus on offering fast solutions to business that currently struggle with securing Food and Drug Administration (FDA) approval to sell their products in the United States under a premarket notification, also known as FDA 510(k) submission.
QPC Services most often works with clients specializing in medical manufacturing including surgical, dental, ophthalmic, biological and pharmaceutical areas of diagnostic devices, instruments, goods and laboratories. “We advise on the latest, fast-track strategies for FDA filing and compliance, and help them avoid the common, costly pitfalls and delays while bringing their products to the market faster so they can immediately start maximizing product revenue.” explains Dunning.
The company works closely with clients such as manufacturers and importers to assess and determine their FDA medical device classification (class 1, 2 and 3 medical devices), product codes, FDA regulation numbers. They also further search for predicate devices already cleared for sale to support their submission process. From there, they identify and assemble the necessary components of the 510(k) application requirements, how they apply to the device and further classify the product as “traditional, abbreviated or special submission” classification.
“Our industry certified experts act as an interface between our client – as an extension of their organization – and the FDA, receiving and responding to critical questions as well as assisting with scheduling and attending inspections conducted by the FDA.” Dunning expands. “And it doesn’t matter if the new product is a drug, biologic, medical device or even a combination; our team has the resources and proven expertise through successfully submitting thousands of medical devices for approval which means our clients obtain FDA 510(k) clearance faster so they can start selling their medical device sooner and start seeing return on investment.”
QPC Services also offers a free, no-obligation consultation available through their website at http://www.qpcservices.biz.
About QPC Services:
QPC equips executives and business owners businesses with the best-practices, people, process and tools they need to eliminate headaches, hassles and financial drain associated with FDA non-compliance issues. For more information on how they can help solve your specific business problems, visit their website or call (877) 355-1702
Tel: (877) - 335 - 1702
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