Provides cost effective medical device consulting services for projects related to compliance with FDA regulations, FDA submissions, 510(k)s, PMAs, FDA inspection readiness, Warning Letter responses, procedures, training, auditing, client and marketing surveys
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Harnack, Gordon
5398 E ●●●●●●●ANCH RD
TU●●ON , AZ, 85739-4270
US
View this contact
Gordon Harnack
Harnack, Gordon
5398 E ●●●●●●●ANCH RD
TU●●ON , AZ, 85739-4270
US
View this contact
EarthLink Network, Inc.
1375 Pe●●●●●●● Street
At●●ta , GA, 30309
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https://fdamaze.com
Provides cost effective medical device consulting services for projects related to compliance with FDA regulations, FDA submissions, 510(k)s, PMAs, FDA inspection readiness, Warning Letter responses, procedures, training, auditing, client and marketing surveys
fdamaze.com
tableofcontents
http://fdamaze.com/index.html
A Medical Device Consulting Firm. Helping FDA Regulated Firms. Master and Manage the FDA Maze". Of Medical Device Compliance. Our Solutions Only Look. Consultants to Worldwide Medical. Device Manufactures Regulated by the. U S Food and Drug Administration. Our medical device consulting services include:. All Medical Device Compliance Activities. All FDA Compliance Activities. Submissions, 510 (k) and PMA. FDA Inspection Readiness and Response. Medical Device Reporting Activities. Tucson, AZ 85739.
tableofcontents
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Oracle consulting Group can provide solutions. To your FDA Medical compliance needs. We would welcome an opportunity to. Understand your needs. It's as easy as 1, 2, 3,:. Simply submit a response on our Request for. We will return a proposal tailored to those. Needs Our proposal will identify our consulting. Service fees and, where practical, estimate the. Project's hours and total costs. Our Proposal can also include our exclusive. Downloadable files) which is our written. To provide you and your firm.
tableofcontents
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Our Free Medical Device. The files listed here are provided in Adobe. Acrobat and may be printed or downloaded. OCG) and may be freely used in their origional form by any. Medical device manufacturer as long they continue to. Demonstrate the quality of our output documents. Non-disclosure Agreement (U.S. Firms and Foreign Firms). US Agent Non-disclosure Agreement. These are Adobe Acrobat files of Oracle Consulting. Group's Non-disclosure Agreements (NDA), with a. Discussion of the downloadable files:.
tableofcontents
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Request for Consulting Service Form. Almost all our consulting services start with a Non-disclosure. Agreement for your protection. We can review yours for. Execution or provide ours. FAX yours to us at 1-520-825-0556. Or request ours below:. Oracle's Non-Disclosure Agreement - Provided in. Adobe Acrobat, by Mail or email. To receive a tailored Consulting Service Agreement, select one or more. Services needed from the options provided. Audits, Internal and Supplier. US Agent or Official Correspondent.
tableofcontents
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Our Quality system Regulation. How to" compliance book,. Mastering and Managing the FDA Maze:. Mastering and Managing the FDA Maze: Medical Device. Written by Gordon Harnack, our managing. Consultant, is published by the American Society for. April 1999). 20 chapters,. 40 figures and almost 300 pages. The book was written for:. Who know their responsibility. To keep their firm's employees trained and competent on. FDA device regulations and require a preliminary desk. Help train and ensure compliance.
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Tucson Health Resources - SurfTucson.com
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Bulldog Lock and Key. Assisted Living and Senior Care. Links Sort by: Hits. Arizona Health Sciences Center. Http:/ www.ahsc.arizona.edu/. Provides health care education, research, patient care, and health related services from the University of Arizona. Includes a health sciences library. Arizona Hearing Specialists: Digital Hearing Aids Tucson Hearing Loss Treatment. Http:/ www.arizonahearing.com. Casa de la Luz Hospice. Http:/ www.casahospice.com/. Http:/ www.academydicapelli.com/. This local group foc...
Tucson Health Resources - SurfTucson.com
http://www.surftucson.com/health
Bulldog Lock and Key. Assisted Living and Senior Care. Links Sort by: Hits. Arizona Health Sciences Center. Http:/ www.ahsc.arizona.edu/. Provides health care education, research, patient care, and health related services from the University of Arizona. Includes a health sciences library. Arizona Hearing Specialists: Digital Hearing Aids Tucson Hearing Loss Treatment. Http:/ www.arizonahearing.com. Casa de la Luz Hospice. Http:/ www.casahospice.com/. Http:/ www.academydicapelli.com/. This local group foc...
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FDA MAP - Regulatory Consulting Services | FDA Compliance Seminar | GMP GCP Training Workshop Conferences
Workshops, Boot-camps and Conferences. One stop source for training, education, and consultation about US FDA processes. Writing Technical Regulatory Documents. ECTD Submission to the US FDA. FDA GMP for Phase I and First-in-Man Clinical Trials. SOPs for FDA-Regulated Industry. For additional information on the workshop agenda and logistics, please call. Or email: info@fdamap.com. Use of this Web site constitutes acceptance of the FDAMap.
FDA Matters
Sequestration Has Less Impact on FDA? August 8th, 2013. The Hill newspaper recently reported that: a survey of federal budgets devoted to developing and enforcing regulations found that many agencies will spend more in 2013 and 2014 than in previous years, indicating that the writing and enforcing of new regulations is largely unimpeded by the massive cuts, known as sequestration. Read the rest of this entry. Posted in FDA and Congress. More Columns Coming; The Alliance for a Stronger FDA. May 24th, 2013.
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