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  • loriacarrinc.com
President and CEO of Lori A. Carr, Inc., is a Principle Consultant in the Medical Device regulated industry... Lori A Carr, qualified FDA regulatory professional consulting with previous FDA medical device experience...

Relevance: 26.330576
  • www.oconnellregulatory.com
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O'CONNELL REGULATORY CONSULTANTS, INC. is a consulting practice which specializes in medical device regulatory affairs and clinical study management, focusing on obtaining FDA marketing approval for medical devices and combination drug/device..

Relevance: 25.999283
  • devicedesignsfda.com
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Device Designs FDA is a full service medical device consulting company specializing in engineering, antimicrobial treatment, device design, regulatory, engineering and technical writing... We can move yo ur devic es speedily through the FDA by doing..

Relevance: 25.87039
  • www.jensmedical.com
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Estaslished in July 2000, Jens Medical Consulting is a Contract Research Organization (CRO) dedicated to assist medical device manufacturer in exploring the complicated regulation worldwide, espeicallysmall entity that doesn't have their regulatory..

Relevance: 25.569017
  • medicaldevice510k.com
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MedicalDevice510k.com is a complete solution to determine whether you should submit a 510k notification to FDA or 510k exempt for your medical device. We made simple and easy to check your product code, device class, regulation, and 510k..

Relevance: 25.277765
  • www.fda510kconsultant.com
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FDA Consulting LLC specializes in regulatory and compliance related submission services to manufacturers, importers, and suppliers of medical devices. Our FDA Consultants are experts in medical device 510(k) submission to FDA for product approval...

Relevance: 25.156507
  • www.janosko.com
I am an experienced Medical Device Regulatory Affairs Consultant. I understand the engineering, manufacturing, marketing and regulatory needs of both large and small medical device manufacturing organizations. My background is rooted in medical..

Relevance: 24.365355
  • www.andrewsconsultants.com
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2005- Present FDA Compliance Consultant to the pharma, biopharma and medical device (drug device combination products) industries... Performed NDA/ANDA/ANADA/NADA Mock Pre-Approval Inspections, cGMP Audits, Pharmacovgilance and Due Diligence..

Relevance: 24.139137
  • www.lighthouseregulatory.com
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We efficiently guide clients navigating the complex medical device regulatory requirements and strive to expedite time-to-market. Our foundation is 15 years of industry and regulatory (FDA) experience which we will apply towards every stage of your..

Relevance: 24.131348
  • www.fdable.com
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Search the FDA FAERS and MAUDE databases (drug and medical device adverse events)...

Relevance: 23.841614
  • corebodytemp.com
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The CORE sensor is the first non-invasive device that continuously and accurately measure Core Body Temperature under real-life conditions. For athletes who are serious about their performance as well as their health and well-being... Medical : CORE..

Relevance: 23.773468
  • www.sdxzsteel.com
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Hangzhou Certificate Bidder Medical Technology Consulting Co., Ltd. is located in Hangzhou, China. It is the third party of medical equipment professional services. To provide customers with one-stop service of medical device laws and regulations,..

Relevance: 23.71727
  • www.mdapprovals.com
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Medical Device Approvals is a Medical Device Regulatory Consulting Company. We provide companies with support in the following areas; FDA regulatory strategy and submissions, assistance with design control and risk management documentation, and..

Relevance: 23.519218
  • excitemedical.com
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Excite Medical is a medical device company based in Tampa, Florida, USA. Excite Medical, registered with the U.S. FDA, holds four FDA 510(k)s including one for the DRX9000®... Excite's flagship product, the DRX9000® , is found in over 1,000..

Relevance: 23.503004
  • www.specialteam.com
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SpecialTeam is an FDA registered and ISO 13485:2016 certified full service Medical Device Contract Manufacturer, located in Yorba Linda, California... SpecialTeam provides turnkey manufacturing, testing, validation, and sterilization services for..

Relevance: 23.502787
  • johnsimon.com
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I have had a variety of experience being directly involved in FDA and Health Canada Audits in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites. Over the years I have..

Relevance: 23.501247
  • www.xfda.com
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We serve a range of clients, from small startups to large pharmaceutical and medical device companies. xFDA can also teach, guide and serve as an auditor and peer reviewer. xFDA is flexible and can supply parts of a team if a company is in need of..

Relevance: 23.413332
  • theallislawfirm.com
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The Allis Law Firm specializes in medical device law and regulation. We assist medical device companies during all stages of a product lifecycle, providing informed and seasoned guidance based on years of experience in private practice and working..

Relevance: 23.290707
  • physcient.com
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Physcient, Incorporated is FDA-registered as a specification developer. Pre-clinical and clinical studies suggest that the DD1 Differential Dissector is safe and effective for blunt dissection. The Differential Dissector is listed on the FDA website..

Relevance: 23.26052
  • www.regenomedix.com
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RegenOMedix™, a division of Zizion® Group, an FDA-registered medical device distributor offering products for Aesthetics, Hair Regeneration, Orthopedics, Sexual Wellness, and Wound Healing... RegenOMedix™ is a medical device distributor providing..

Relevance: 23.225515
  • www.mdrsllc.com
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MDRS, LLC is an FDA registered company that specializes in providing strategic FDA and global regulatory, product development, quality and clinical research support to medical device and biotechnology companies and their development teams... MDRS,..

Relevance: 23.146757
  • www.meddeviceconsulting.com
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RedEdge Consulting is committed to helping clients find the most cost-effective method for achieving quality goals and regulatory compliance. By working closely with my clients, I can design, implement, and evaluate the systems and documentation..

Relevance: 23.080435
  • www.medrig.com
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In 2008, MEDRIG Medical Device Consulting Co.,Ltd. was founded in New Jersey to assist domestic medical device manufactures with compliance with FDA 510k regulations. And also being a parnter with US labratories and third parties, we source suitable..

Relevance: 23.05598
  • enemconsulting.com
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ENEM Consulting is a consulting business medical device industry liaison for the FDA and medical device companies. We offer services online at your location, and we are a life sciences regulatory consulting company providing clients with..

Relevance: 22.835478
  • fdapals.com
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FDApals is your partner for all your FDA Registration and FDA Approvals. We are your go to FDA consultant for all your regulatory needs right from FDA registration to warning letters replies and compliance. We at FDApals ensure 100% compliance with..

Relevance: 22.814611
  • mrregulatory.com
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Whether you're a seasoned regulatory affairs professional, FDA staffer, or someone looking to enter the field, we provide insights into how the agency works and how to communicate with FDA through the complex regulatory landscape to ultimately bring..

Relevance: 22.788994
  • www.sttassociates.com
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STT Associates specializes in bridging the gap between complex medical device data and actionable business insights. Our team combines deep technical expertise in data analytics with comprehensive understanding of the medical device industry... From..

Relevance: 22.705168
  • www.fda-inspection.us
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FDA inspect establishments that manufacture, process or pack FDA regulated products like medical device, drug, cosmetic, food etc. FDA conduct random inspection with short notice to verify the GMP compliance. FDA ORA (office of Regulatory Affairs) is..

Relevance: 22.661037
  • www.bustoslawgroup.com
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Bustos Law Group is an FDA compliance firm that provides legal services for companies in the food, medical device, cosmetics, and dietary supplement industries... Get comprehensive FDA compliance lawyer services with Bustos Law Group. Our firm..

Relevance: 22.645954
  • www.mtech-inc.net
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As a regulatory consulting company, Mtech Group consultants have professional experience and expertise to assist our customers with the best available medical science and practice in the industry... We understand the challenges the medical device..

Relevance: 22.624838