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510k Clearance with FDA Compliance510k Clearance FDA Compliance
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510k Clearance FDA Compliance
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Brittle and Company, Inc.
walter Brittle
1289 N.●●●●●●●m Blvd.
Suit●●●●-128
Chap●●●●Hill , North Carolina, 27517
United States
View this contact
Brittle and Company, Inc.
walter Brittle
1289 N.●●●●●●●m Blvd.
Suit●●●●-128
Chap●●●●Hill , North Carolina, 27517
United States
View this contact
Brittle and Company, Inc.
walter Brittle
1289 N.●●●●●●●m Blvd.
Suit●●●●-128
Chap●●●●Hill , North Carolina, 27517
United States
View this contact
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510k Clearance with FDA Compliance | fdacompliancehelp.com Reviews
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510k Clearance FDA Compliance
ISO 19011:2002 Guidelines for Quality Management Systems Audit
http://www.fdacompliancehelp.com/AUDITING
ABOUT FDA COMPLIANCE AUDITING. Our compliance auditing service is a cost effective and timely way of meeting the FDA "independence and qualification". Requirements for internal audits and supplier audits. It also offers management peace of mind in preparation for an announced FDA inspection. Audits follow ISO 19011:2002 Guidelines for Quality Management Systems Audit. More than 10 years auditing experience. Specialties: Sterilization, Water, Sterile Device Manufacturing. Phone: 919.942.1634.
FDA Compliance Help|Auditing|510K Clearance|Quality Systems
http://www.fdacompliancehelp.com/WHO_WE_ARE
FDA Compliance Help is a specialized medical device quality and regulatory compliance consulting firm. The company was founded in 2004 by Walt Brittle, Managing Partner. He serves as lead consultant, supported by fully qualified contract consultants, as needed. Jennifer Brittle, services as office manager. 101 Wicklow PL. Chapel Hill, NC 27517 USA. Phone: 919.942.1634.
FDA Compliance Help|Auditing|510K Clearance|Quality Systems
http://www.fdacompliancehelp.com/QUALITY_SYSTEMS
It's the Law, All Medical Device Firms must have a Quality Management System. We will bring extensive experience to bare and develop a custom quality management system. By utilizing our sizable library of templates as a starting point saves time and cost when creating the custom QMS. Our employee training videos offer rapid implementation an reusable asset to train new employees. 101 Wicklow PL. Chapel Hill, NC 27517 USA. Phone: 919.942.1634.
What every medical device CEO needs to know
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What every medical device CEO needs to know. The FDA regulates over 1 trillion dollars' worth of products, which accounts for 22 cents of every dollar spent annually by American consumers. The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action. 101 Wicklow PL. Chapel Hill, NC 27517 USA. Phone: 919.942.1634.
FDA Compliance Help|Auditing|510K Clearance|Quality Systems
http://www.fdacompliancehelp.com/REMITTANCE
Credit card payments accepted. Hosted by PayPal, most popular credit cards are accepted including Visa, MasterCard, and more. To make a payment, click on the "add to Cart" button and enter the number of whole dollars in the units field. For example, if your invoice totaled $1,235.25, after clicking on the add to cart button, enter 1235 in the units field, click on the update button, then proceed to checkout. 101 Wicklow PL. Chapel Hill, NC 27517 USA. Phone: 919.942.1634.
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FDA Compliance Help|Auditing|510K Clearance|Quality Systems
http://brittle.com/index.php
FDA Compliance Help is a specialized medical device quality and regulatory compliance consulting firm. The company was founded in 2004 by Walt Brittle, Managing Partner. He serves as lead consultant, supported by fully qualified contract consultants, as needed. Jennifer Brittle, services as office manager. 101 Wicklow PL. Chapel Hill, NC 27517 USA. Phone: 919.942.1634.
fdacompliancehelp.blogspot.com
FDA Compliance Help: August 2012
http://fdacompliancehelp.blogspot.com/2012_08_01_archive.html
FDA Compliance Help for medical device firms. Website - http:/ FDAcomplianceHelp.com. Monday, August 13, 2012. What will the FDA Safety and Innovation Act [FDASIA] of 2012 Mean to You? If you operate or serve as a QA/RA department head of a medical device establishment FDASIA will be meaningful to you. In this article we cover the key elements of the Act that concern medical device establishments. MDUFA III will take effect on October 1, 2012 and will sunset in five years on October 1, 2017. Minimize the...
FDA Compliance Help|Auditing|510K Clearance|Quality Systems
http://brittle.com/waltbrittlecv.php
Thirty-five years of experience in regulatory compliance, manufacturing, research and development, and clinical practice. Competency in contract sterilization, single-use device reprocessing, sterility assurance products, endoscopes, surgical drapes, medical textiles, biological products, hospital supplies, specialized medical electronic devices, complex diagnostic systems, optics, laser systems, surgical instruments, microsurgery, and fiber optics. Fourteen-month warning letter remediation for a prescri...
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GCP GLP GMP Auditing for FDA Compliance - EHKrohl Consulting, Inc. :: Home
From the moment of discovery of a promising new drug or medical device, to the actual delivery of product to the market, virtually every step in the process involves compliance with federal regulations - the FDA, a fact of life that makes time a relentless adversary. Rohl Consulting, Inc. helps companies reduce the time it takes to put their products on the market by educating and assisting Quality Assurance. Personnel in implementing FDA. Relative to Good Clinical Practices, GCP.
GCP GLP GMP Auditing for FDA Compliance - EHKrohl Consulting, Inc. :: Home
From the moment of discovery of a promising new drug or medical device, to the actual delivery of product to the market, virtually every step in the process involves compliance with federal regulations - the FDA, a fact of life that makes time a relentless adversary. Rohl Consulting, Inc. helps companies reduce the time it takes to put their products on the market by educating and assisting Quality Assurance. Personnel in implementing FDA. Relative to Good Clinical Practices, GCP.
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fdacompliancehelp.blogspot.com
FDA Compliance Help
FDA Compliance Help for medical device firms. Website - http:/ FDAcomplianceHelp.com. Thursday, March 7, 2013. Are you using the FDA’s FOIA to your advantage? Unless you have a FOIA “owner” copy (not redacted) of FDA’s Establishment Inspection Reports for your facilities and premarket clearance and approval reports for all your devices you are not taking advantage of a valuable intelligence resource. The good news is the FDA has made it easy with the FOIA internet portal. 12420 Parklawn Drive, Room 1050,.
510k Clearance with FDA Compliance
Don't know where to start? Our no obligation situation analysis will identify your specific regulatory requirements and a practical cost effective pathway to compliance. Get to market fast. Creating a 200 400 page submission is a daunting task. By getting to market faster you will more than pay for the cost of our services! A fresh set of experienced eyes not only assures the required independence, but also identifies opportunities for improvement. Supplier audits up to date? Our auditors can help. The f...
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Venta de equipos de cómputo, Redes, Impresoras, Diseño Web y soporte técnico - FDA COMPUTER S.A.C.
FAIL (the browser should render some flash content, not this). Nos dedicamos a brindar soluciones en el rubro de venta, soporte técnico de equipos de cómputo y puntos de venta, para cualquier tipo de negocio o empresa: Grifos, Ferreterías, Restaurantes, Bares, Fast Food, Supermercados, Boutiques, Librerias, Bazares, Discotecas, Hoteles, Tiendas, Farmacias, etc. TRABAJAMOS CON LAS MEJORES MARCAS:.
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