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QSOne Inc. is a global medical device consulting company that intends to provide third party service and manufacturing assistance to medical device companies worldwide from define phase to implement phase by using our full knowledge of the device arena with correct gated process implementation.

The service segment of QSOne Inc. can provide full approval process support with the United States Food and Drug Administration (FDA) on the behalf of European and Asian medical device companies. QSOne Inc. can provide inroads to U.S. medical device companies with CE Mark registration that desire to manufacture and sell their products in the European Union (E.U.) and Asia.

Venture History

QSOne was incorporated on December of 2001 with mission to provide FDA regulatory support to meet the needs of global pharmaceutical and medical device clients that wish to manufacture and sell their products domestically and worldwide. QSOne, Inc. will open global markets to small and medium size medical device companies while providing its shareholders with a respectable return on investment.

Venture History Keys to Success

QSOne, Inc. will consistently provide hands-on leadership in the regulated medical technology industries and to be the only vendor-of-choice for regulatory assistance, comprehensive consulting services, and custom manufacturing support expertise in an increasingly competitive marketplace.

QSOne, Inc. will provide personal business expertise to all our customers within the full range of regulatory assistance, comprehensive consulting services, and custom manufacturing support, and provide the support required to execute these services effectively to completion.

QSOne, Inc. will focus on continuous improvement and quality enhancements through attention to detail and consistent feedback, in order to provide continuous value added support internally and externally to customers and associates.

QSOne, Inc. will help our customers' execute efficiently and consistently from initial design concepts to final delivery so they can reach the market in the most efficient manner and the most planned fashion possible.

QSOne, Inc. will share its success with all internal and external contacts and associations of any kind, whether in a civil responsibility, environmental responsibility, or business responsible and ethical environment at all times

Venture Description

QSOne Inc. is a global medical device consulting company that intends to provide third party service and manufacturing assistance to medical device companies worldwide from define phase to implement phase by using our complete knowledge of the device arena with correct gated process implementation.

QSOne Inc. can provide full approval process support with the United States Food and Drug Administration (FDA) on behalf of European and Asian medical device companies that are looking for making business in United States. At the same time, QSOne Inc. can provide inroads to U.S. medical device companies that desire to manufacture and sell their products in the European Union (E.U.) and Asia.

Besides, the distribution branch of QSOne Inc. has the intention of distributing products in United States with the aim to bring support to the medical device manufacturers. The main focus is on commodity devices and components for the medical device industry.

QSOne, Inc. can provide:

International companies assistance in entering the United States, European and Asian markets.

Products

In today's global economy, executing your project on time and within budget requires the expertise of global specialist to obtain market access and maximize your organization's success. We also sell most medical products including Gloves, syringes, wheelchairs and more.

To support you in your next project, QSOne Inc. has designed the Products section of our website, providing information on our individual services available for the industry we serve. QSOne services include:

Manufacturing

> Process IQ, OQ, PQ – Protocols and Reports

> Metrology

> Inspection Systems

> Six Sigma (Training and Systems)

> Lean Manufacturing and SPC

> Medical Product Launch Process (MPLP)

> Method Validation

> Method Development

> Internal Audits

> Supplier Audits

> FDA and ISO Inspection Assistance

Training

> Quality Systems (ISO/ GMP/ EN/ QSR/ GCP/ GLP)

> Six Sigma

> Statistics

> Internal/ External audits

> CAPA Corrective and Preventative Action

> QSIT Quality Systems Inspection Techniques