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Our Company

Why Virtue Quality Consultants, Inc.?

We provide comprehensive solutions and strategies to support the design development, manufacturing and the regulatory approval process for your medical device, pharmaceutical and consumer base products.  Our experienced and savvy consultants draw their expertise from decades of hands-on experience utilizing the best practices and methods for a systematic approach in supporting our customer needs.

Our goal is to bridge the gap between the regulatory needs while providing optimal solutions for a very comprehensive and effective advice and assistance with successful implementation.

Our team solutions are directly in-line with the most current regulatory standards governing the development of your products. Some of these include ISO9001- Quality Management Systems, ISO14971 - Risk Management, ISO13485 - Medical Device Quality Management Systems, EU MDR, MDSAP and many more. So, whether you want our help for both domestic or international challenges our team will work with your company staff side-by-side diligently to the get the job done. 

Mission Statement

Our Mission

Our mission is to contribute to the success of our clients by providing guidance and support faced with challenges and opportunities posed by regulatory compliance issues. Our role is to act as a unbiased advisor, provide objective analysis, sound solutions and effective implementation.

 

Our Values

At Virtue Quality Consultants our day to day activities always reflect our T. E. A. M. core values. 

  • Time 

  • Evaluate

  • Accomplishable

  • Meaningful

1. Time

All projects are time-sensitive this why its critical to ensure everyone knows what they are doing upfront backed by a project plan. This clarity allows the consultants to be most productive and avoid time wasting practices at all cost. 

2. Evaluate

The aim for project evaluation is to determine the relevancy and fulfillment of the efficiency , effectiveness , impact and sustainability of the set goals & objectives. 

3. Accomplishable

We believe that the correct consultants (resources) with the appropriate skill set will deliver the highest quality work maximizing efficiency and minimizing confusion to accomplish the task at hand. 

4. Meaningful

Success is measured by how well did the goals and objectives of the project met the expected final devliery. However, true success is established when total satisfaction of the customer has been met. Did we solve the problem? Did we achieve the right benefits? Did we deliver the right service?

 

We are values driven consulting firm that aims not to be the biggest, but to be the best. We believe our successes only exist if our clients are successful. 

 

Connect with Us

Virtue Quality Consultants, Inc. would like to provide you with regulatory and quality solutions that will help your company achieve its goals.

 

 

TEL:

239-287-0673

MAIL:

Info@virtuequalityconsultants.com

 

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News & Publications
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The Food and Drug Administration (FDA) has a “strong interest” in changing its quality system requirements for medical device manufacturers to utilize the International Organization for Standardization’s (ISO) updated quality management standard, 13485:2016.

Our Strengths
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MDSAP frequently asked questions. 


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EU MDR 2017/745 and EU MDR 2017/746


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ISO 14971 Risk Management: 2019

The third edition of ISO 14971 was finally released in December 2019 and it replaces ISO 14971:2007. Overall, no tectonic shifts have occurred the risk management process itself remains largely unchanged. Nonetheless, there are important clarifications and updates in ISO 14971:2019 that you should be aware of.

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