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Home - FDA Consulting, LLCFDA Consulting, LLC offers FDA regulatory compliance consulting for medical device and in vitro diagnostics. Domestic. International. ISO 13485. FDA 510k.
http://www.fda-consulting.com/
FDA Consulting, LLC offers FDA regulatory compliance consulting for medical device and in vitro diagnostics. Domestic. International. ISO 13485. FDA 510k.
http://www.fda-consulting.com/
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FDA Consulting, LLC
Michael Wienholt
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Esc●●●ido , CA, 92025
US
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FDA Consulting, LLC
Michael Wienholt
2415 P●●●●●●el Mar
Esc●●●ido , CA, 92025
US
View this contact
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Home - FDA Consulting, LLC | fda-consulting.com Reviews
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FDA Consulting, LLC offers FDA regulatory compliance consulting for medical device and in vitro diagnostics. Domestic. International. ISO 13485. FDA 510k.
fda-consulting.com
FDA Consulting, LLC - Case Studies
http://www.fda-consulting.com/case-studies
Designing a ISO 13485 - Compliant Quality Management System. Kestrel BioSciences, LLC. The client received its certificate of registration to the standard from BSi on October 16, 2014 - only 6 months after we started the project. FDA 510(k) NSE Decision is Remediated. IVD Research, Inc. The new 510(k) was submitted to FDA, resulting in market clearance for the test less than 8 months after the original submission was rejected. Or send us an email. Website Design by J3 Designs. FDA Consulting, LLC.
FDA Consulting, LLC - Client Comments
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What people are saying. CFO at Concentric Analgestics, Inc. President at Kestrel BioSciences. President and CEO at Medical Devices and Diagnostics. Medical and Scientific Affairs Executive. President and CEO at KFx Corporation. In my opinion, it is hard to saying anything better about Michael than after he worked for me for a number of years, I hired him again. And would do so again! President at IVD Research Inc. Michael was critical to my companies FDA 510(k) applications. He came highly recommende...
FDA Consulting, LLC - Blog
http://www.fda-consulting.com/blog
Welcome to our blog! We hope that you will find it both informative and useful. 13485 Does Not Equal 820. May 27, 2015. For the times they are a-changin' " - Start Now to Prepare For The Pending EU Medical Device Regulation. Mar 20, 2015. Alphabet Soup: ISO 13485:2003, BS EN ISO 13485:2012 or DIN EN ISO 13485:2012? Jan 31, 2015. Jan 6, 2015. To schedule an appointment or find out more about the services we offer, please call (760) 532-6304. Or send us an email. Website Design by J3 Designs.
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FDA Consulting, LLC.
FDA 510(k), FDA PMA, CE marking, quality systems consulting.
http://www.fda-consulting.com/services
FDA Consulting, LLC can assist you with a wide range of domestic and international regulatory affairs and quality system requirements. We maintain effective working relationships with managers and reviewers in FDA CDRH. We have direct experience working with a number of industry experts in product-specific requirements, including product safety engineering to IEC standards, sterilization validation, biocompatibility testing, packaging validation and FDA and IEC laser safety regulations.
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510k fda consultants regulatory affairs cdrh iso gmp aami ec Mark ansi compliance
Do you have a. Send us a Message! Compliance Consultants is a recognized leader in developing new medical devices and obtaining U.S. Food and Drug Administration "approval" for medical devices. We assist inventors world wide in developing new medical devices and shaping devices to fit through the FDA approval process. Why we are different. How we can charge less for more! Stamford, CT 06907 USA. Voice 203 329 2700 Fax 203 329 2345.
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KAMM & ASSOCIATES International FDA Consulting
Assisting the Medical Device Community with FDA regulatory services. Working Worldwide Since 1990. FDA Submissions: 510(K), IDE, PMA, Product Reports. (Over 300 successful 510(k) clearances). See additional 510(k) information below. Medical Device License Submissions for CANADA: Canadian Medical Device License Information. Barcodes now required on most medical devices. FDA 483 and WARNING LETTER: Strategies and Responses. CGMP Compliance Programs: AUDITING - CONSULTING. The fee changes each year. Sterili...
Home - FDA Consulting, LLC
Regulatory Affairs Quality Systems Consulting Services for the Medical Devices and In Vitro Diagnostics Industries. WE CAN ASSIST YOU IN UNDERSTANDING DOMESTIC AND INTERNATIONAL REGULATIONS AND DELIVERING YOUR PRODUCTS TO MARKET IN A TIMELY FASHION. CONTACT US FOR AN INITIAL CONSULTATION. FDA Consulting, LLC.
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