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Quality System Strategies LLC - Home

The mission of Quality System Strategies LLC. Is to assist medical device companies in establishing quality management systems that. Facilitate compliance with regulations. Increase business efficiency, and thereby. Provide a competitive advantage in the marketplace. How to do it:. Aim beyond compliance. Compliance alone is not enough. Simplify documentation. People have to understand what they are expected to do. Connect all the processes. Disconnected processes lead to unhappy customers and worse.

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The mission of Quality System Strategies LLC. Is to assist medical device companies in establishing quality management systems that. Facilitate compliance with regulations. Increase business efficiency, and thereby. Provide a competitive advantage in the marketplace. How to do it:. Aim beyond compliance. Compliance alone is not enough. Simplify documentation. People have to understand what they are expected to do. Connect all the processes. Disconnected processes lead to unhappy customers and worse.
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5 senior consultant
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Quality System Strategies LLC - Home | qualitysystemstrategies.com Reviews

https://qualitysystemstrategies.com

The mission of Quality System Strategies LLC. Is to assist medical device companies in establishing quality management systems that. Facilitate compliance with regulations. Increase business efficiency, and thereby. Provide a competitive advantage in the marketplace. How to do it:. Aim beyond compliance. Compliance alone is not enough. Simplify documentation. People have to understand what they are expected to do. Connect all the processes. Disconnected processes lead to unhappy customers and worse.

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1

Quality System Strategies LLC - Philosophy

http://www.qualitysystemstrategies.com/philosophy.html

Quality Management Systems: Requirements. Each company selling medical devices in the U.S. must implement a quality management system that fulfills the requirements of 21 CFR 820, known as the Quality System Regulation. Selling in Canada, in the countries of the European Union, and in an increasing number of other countries around the world also means implementing the requirements of the ISO 13485:2003 quality standard, as well as special requirements for particular countries. A third level of documentat...

2

Quality System Strategies LLC - Services

http://www.qualitysystemstrategies.com/services.html

These services have been provided to multiple clients. Guidance / assistance to establish effective / efficient quality management system documentation for medical device companies. Quality manuals that are readable and provide employees an overview of the principles behind the quality management system. Level 3 procedures spelling out step by step how the requirements of Level 2 documentation must be fulfilled, usually supported by flow charts and text closely related to the flowcharts. Measuring intern...

3

Quality System Strategies LLC - Home

http://www.qualitysystemstrategies.com/home.html

The mission of Quality System Strategies LLC. Is to assist medical device companies in establishing quality management systems that. Facilitate compliance with regulations. Increase business efficiency, and thereby. Provide a competitive advantage in the marketplace. How to do it:. Aim beyond compliance. Compliance alone is not enough. Simplify documentation. People have to understand what they are expected to do. Connect all the processes. Disconnected processes lead to unhappy customers and worse.

4

Quality System Strategies LLC - About

http://www.qualitysystemstrategies.com/about.html

Dr White holds an A.B. in Chemistry from Harvard College and a PhD in Chemistry from Cornell University. American Society for Quality. ASQ Midwest Biomedical Discussion Group. Association for the Advancement of Medical Instrumentation. Regulatory Affairs Professional Society. 2011 Quality System Strategies LLC. Telephone: 574.361.0816.

5

Quality System Strategies LLC - Useful Links

http://www.qualitysystemstrategies.com/usefullinks.html

FDA Center for Devices and Radiological Health. A good starting point for locating US regulations and guidance. Source for Canadian Medical Device Regulations, information about product licenses and guidance documents. European Commission Webpage for Medical Devices. The EC website is understandably complex, but this reference can lead to important documents such as the device directives and information about harmonized standards. International Medical Device Regulators Forum.

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LINKS TO THIS WEBSITE

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Free Documents and Websites

http://www.compliance-alliance.com/free-documents-and-websites

Free Documents and Websites. Compliance Program Guidance Manual. Points To Consider for the QSIT Design Controls Subsystem. Points to Consider for the QSIT Corrective and Preventive Actions (CAPA) Subsystem. Points to Consider for the QSIT Management Controls Subsystem. Medical Device Inspections: Required Reading. Wishing for A Compliant CAPA System. Guide to Inspections of Foreign Medical Device Manufacturers. Laws Enforced By the Food and Drug Administration. ORA Field Management Directive.

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Quality System Strategies LLC - Home

The mission of Quality System Strategies LLC. Is to assist medical device companies in establishing quality management systems that. Facilitate compliance with regulations. Increase business efficiency, and thereby. Provide a competitive advantage in the marketplace. How to do it:. Aim beyond compliance. Compliance alone is not enough. Simplify documentation. People have to understand what they are expected to do. Connect all the processes. Disconnected processes lead to unhappy customers and worse.

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