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COMPLIANCEACUITY.COM

Compliance Acuity | Medical Device Regulatory Consultant

ComplianceAcuity provides customized, common-sense solutions to achieve sustainable regulatory affairs and quality systems in the medical device and pharma industry. We excel by pairing intelligent business planning with strategic regulatory and quality systems.

http://www.complianceacuity.com/

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Compliance Acuity | Medical Device Regulatory Consultant | complianceacuity.com Reviews
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ComplianceAcuity provides customized, common-sense solutions to achieve sustainable regulatory affairs and quality systems in the medical device and pharma industry. We excel by pairing intelligent business planning with strategic regulatory and quality systems.
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Compliance Acuity | Medical Device Regulatory Consultant | complianceacuity.com Reviews

https://complianceacuity.com

ComplianceAcuity provides customized, common-sense solutions to achieve sustainable regulatory affairs and quality systems in the medical device and pharma industry. We excel by pairing intelligent business planning with strategic regulatory and quality systems.

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1

Compliance Acuity | Site Map

http://www.complianceacuity.com/site-map

Compliance Intervention and Regulatory Affairs:. FDA / Third-Party Audit Support. FDA 483, Warning Letters, Other Agency Citations. Liaison with Regulatory Agencies. Recalls and Safety Alerts. Establishment Registration / Device Listings. Quality Management Systems (QMS):. Corrective and Preventive Action (CAPA). Design Controls / Product Development. Production and Process Control. 8 am - 6 pm MST, M-F. 2010-2016 ComplianceAcuity, Inc.

2

Compliance Acuity | Testimonials

http://www.complianceacuity.com/medical-device-regulatory-testimonials

To guard confidentiality, client contact info is not posted here, but is immediately available by request. Click on a link below for topically-arranged ComplianceAcuity client testimonials. FDA 483 and Warning Letter Resolution. Design Controls / Product Development. 8 am - 6 pm MST, M-F. 2010-2016 ComplianceAcuity, Inc.

3

Compliance Acuity | Medical Device Regulatory Services

http://www.complianceacuity.com/medical-device-regulatory-services

You were able to integrate with company staff and work alongside them as if an employee and thus were able to complete the tasks while simultaneously achieve acceptance by internal staff and employeesWe would highly recommend ComplianceAcuity to other companies requiring assistance in developing their QMS, for supporting regulatory audits, internal audits and regulatory compliance. President and CEO Medical Device Manufacturer. Compliance Intervention and Regulatory Affairs:. Recalls and Safety Alerts.

4

Compliance Acuity | Articles & Whitepapers

http://www.complianceacuity.com/medical-device-regulatory-articles-whitepapers

Kevin is able to explain complex issues in an easy to understand way. President and Founder, class II devices. To request the below articles and whitepapers, please contact us: info@complianceacuity.com. A Four-Tiered Approach to Comprehensive Complaint Handling Integrated with CAPA,. A guidance document by Kevin Randall, RAC (U.S., EU, CAN). Venture Capitalist Medical Device Development: Maximizing ROI in an FDA-Regulated Environment,. By Kevin Randall, RAC (U.S., EU, CAN). Infusing the business plan wi...

5

Compliance Acuity | About Us

http://www.complianceacuity.com/medical-device-regulatory-about

President and CEO, Class II Devices. Kevin Randall is Principal Consultant at ComplianceAcuity. Be sure to visit his LinkedIn page. Since entering the profession in 1995, Kevin has continuously contributed to the business goals of medical device companies ranging from small start-ups to large international enterprises. 20 years building sustainable quality systems and compliance operations. Acclaimed quality systems instructor. Supported where needed by an elite team of globally-certified regulatory, cli...

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LINKS TO THIS WEBSITE

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510kExperts.com - Articles

http://www.510kexperts.com/pb/wp_9e942fa9/wp_9e942fa9.html

Please visit us at. For more information while this page is under development. 2007-2013 ComplianceAcuity, Inc. 2000 - 2013 powered by.

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510kExperts.com - Contact Us

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Please visit us at. For more information while this page is under development. 2007-2013 ComplianceAcuity, Inc. 2000 - 2013 powered by.

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510kExperts.com - About Us

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Please visit us at. For more information while this page is under development. 2007-2013 ComplianceAcuity, Inc. 2000 - 2013 powered by.

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510kExperts.com - Services

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Please visit us at. For more information while this page is under development. 2007-2013 ComplianceAcuity, Inc. 2000 - 2013 powered by.

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510kExperts.com - Home

http://www.510kexperts.com/index.html

Advance Your Business Now. For visiting our new FDA 510(k) website CURRENTLY UNDER DEVELOPMENT. And we are pleased to offer you our proven expertise in getting your medical device cleared for. Food and Drug Administration. While this sub-site is being developed, please don't hesitate to visit our primary website or contact us for a realistic assessment. Of your 510(k) needs. A clear estimate of our fees will be provided quickly at your request. You can reach us at. 510(k) because we KNOW what FDA expects.

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510kExperts.com - Links

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Please visit us at. For more information while this page is under development. 2007-2013 ComplianceAcuity, Inc. 2000 - 2013 powered by.

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Compliance Acuity | Medical Device Regulatory Consultant

Content on this page requires a newer version of Adobe Flash Player. Provides customized, common-sense solutions to achieve sustainable regulatory affairs and quality systems in the medical device and pharma industry. We excel by pairing intelligent business planning with strategic regulatory and quality systems. Final draft of New ISO 13485 Medical Devices Quality Management System Standard published. FDA DRAFT guidance for animal studies of medical devices. 2010-2018 ComplianceAcuity, Inc.

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Compliance Admin - A Meritain Health Company. We believe in one. One company. One vision. Compliance Administrators has joined forces with Meritain Health. To visit our new corporate web site, please visit www.meritain.com. Employers can log in to their personalized site, by visiting www.meritain.com. And clicking on the tab for Employers.

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