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Van Hoven Consulting, LTD is a regulatory and quality consultancy specializing in medical product regulatory filings for the United States, Canada, and the European Union.   President and...

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CONTACTS AT VANHOVENCONSULTING.COM

Van Hoven Consulting

John Van Hoven

2717 Fi●●●●●●● Street

De●●er , Colorado, 80205

UNITED STATES

1303●●●●8938
jo●●●●●●●●●●@gmail.com

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Van Hoven Consulting

John Van Hoven

2717 Fi●●●●●●● Street

De●●er , Colorado, 80205

UNITED STATES

1303●●●●8938
jo●●●●●●●●●●@gmail.com

View this contact

Van Hoven Consulting

John Van Hoven

2717 Fi●●●●●●● Street

De●●er , Colorado, 80205

UNITED STATES

1303●●●●8938
jo●●●●●●●●●●@gmail.com

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Van Hoven Consulting, LTD is a regulatory and quality consultancy specializing in medical product regulatory filings for the United States, Canada, and the European Union.   President and...
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Van Hoven Consulting, LTD - Home | vanhovenconsulting.com Reviews

https://vanhovenconsulting.com

Van Hoven Consulting, LTD is a regulatory and quality consultancy specializing in medical product regulatory filings for the United States, Canada, and the European Union.   President and...

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1

510(k) Applications - Van Hoven Consulting, LTD

http://www.vanhovenconsulting.com/510k-applications.html

Clinical Trial Design and IRB Applications. United States FDA 510(k) Premarket Notification Applications. Van Hoven Consulting specializes in authoring and submitting 510(k) premarket notification applications for new Class I or Class II medical products. Having authored numerous 510(k) applications for different medical products, Van Hoven Consulting offers a broad spectrum of experience and insight to help you put together a 510(k) application that will withstand, and pass, FDA scrutiny and review.

2

510(k) Remediation - Van Hoven Consulting, LTD

http://www.vanhovenconsulting.com/510k-remediation.html

Clinical Trial Design and IRB Applications. United States 510(k) Premarket Notification Remediation. With FDA's updated practice of allowing only a single Additional Information (AI) Response before rendering their SE / NSE determination, it is increasingly important to effectively respond to FDA AI questions the first time. Responses to FDA AI questions need to be well crafted, thorough and concise, while leaving no point unaddressed. Van Hoven Consulting has extensive experience addressing FDA question...

3

Services - Van Hoven Consulting, LTD

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

Clinical Trial Design and IRB Applications. Van Hoven Consulting offers a number of services related to marketing new or existing medical products in the United States, Canada, the European Union, and other countries. Van Hoven Consulting services Include:. US 510(k) Application writing. EU Technical File writing. Clinical Trial Design and IRB Application writing. Contact VHC today to discuss your regulatory and quality system needs. University, Incubator, and SBIR Discounts. Proudly powered by Weebly.

4

EU Technical Files - Van Hoven Consulting, LTD

http://www.vanhovenconsulting.com/eu-technical-files.html

Clinical Trial Design and IRB Applications. European Union Technical Documentation - MDD 93/42/EEC. Van Hoven Consulting is available to help with the following:. Does your product meets the definition for a medical product in the EU? What class is your medical product? What Technical File content do you need to have for your new product? How to document compliance to recognized consensus standards? Content of Declarations of Conformity. How to select the appropriate notified body?

5

About John - Van Hoven Consulting, LTD

http://www.vanhovenconsulting.com/about-john.html

Clinical Trial Design and IRB Applications. John Van Hoven, BA, MS. If you're unsure of the regulatory and scientific landscape for your new medical product, contact me today to discuss how I might be able to help you. Proudly powered by Weebly.

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Van Hoven Consulting, LTD - Home

Clinical Trial Design and IRB Applications. Van Hoven Consulting, LTD. A regulatory and quality consultancy specializing in medical product regulatory filings for the United States, Canada, and the European Union. Administration, and more. Prior to his regulatory work, John spent 7 years in academic research at the University of Colorado, Denver and the National Institutes of Health. The VHC mission is to provided accurate, thorough and affordable consulting services that exceed your expectations. In...

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