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In a world of challenging and dynamic regulation, effective
management of quality and regulatory issues is essential to the maintenance of your business and to new product introduction.
This requires a robust system for handling quality and regulatory issues, as well as detailed knowledge of particular requirements.
RedEge
Consulting is a leading provider of medical device consulting services for companies in need of solutions concerning the implementation
of a compliance program. Let RedEdge Consulting assist you on the way to the markets of the world.
I can help you plan
product development and provide advice and support for preparation of 510(k), IDE, PMA and CE Mark submissions. For European
markets, I provide a full spectrum of services designed to assure that you meet the requirements of the Medical Device Directives
(MDD).
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RedEdge Consulting provides compliance solutions to meet all
aspects of CDRH/FDA requirements and ISO quality systems. Capabilities include development of regulatory strategies, preparation
of clinical trial documents (NSR and IDE submissions),
510(k)s, development of quality system to comply with QSR/ISO 9001/ISO
13485 implementation, audits, training, design controls, process validation, FDA-483, and warning letter recovery.
The
goal of RedEdge Consulting is to meet the increasing design and system needs of the industry, and the upsurge of medical device
outsourcing services.
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