Company Profile for Emergo Group, Inc.Emergo Group assists medical device and IVD companies with regulatory affairs, quality assurance and distributor search consulting. Since 1997, we have assisted more than 1,000 companies and maintain offices in the US, Europe, Japan, China, Canada and Australia. Our services include: * UNITED STATES: 510(k) submissions, GMP GMP (guanosine monophosphate): see guanine. quality system implementation, auditing and training, Form 483 and Warning Letter recovery, ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 14971:2007 risk management, validation consulting and distributor search. * EUROPE: Authorized Representation for CE Marking, Technical File preparation or review, ISO 13485:2003 implementation, auditing and training, EU distributor search and qualification. * JAPAN: Designated Marketing Authorization Holder (D-MAH), JPAL JPAL Joint Precision Approach and Landing System compliance, MHLW MHLW Ministry of Health, Labor and Welfare (Japan; formerly Ministry of Health and Welfare, MHW) MHLW Mean High Low Water (tide level) Ordinance #169 consulting, Seihin Hyojun Sho file creation, reimbursement consulting and STED n. 1. See Stead, Steadfast, etc. preparation. * CHINA: SFDA SFDA State Food and Drug Administration (China) SFDA Saudi Food & Drug Authority medical device approvals, Legal Agent and After Sales Agent representation, CCC CCC A very speculative grade assigned to a debt obligation by a rating agency. Such a rating indicates default or considerable doubt that interest will be paid or principal repaid. Also called Caa. Mark certification consulting and clinical trial research. * CANADA: Medical Device Establishment License, ISO 13485:2003 modification, CMDR consulting, ISO 13485 training, distributor search and qualification. * AUSTRALIA: TGA Sponsor representation, device registration and STED preparation.
Company: <
Emergo Group, Inc.
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Headquarters Address: <
1705 S. Capital of Texas Highway
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Suite 500
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Austin, TX 78746
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Main Telephone: <
1-512-327-9997
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Website: <
www.EmergoGroup.com
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Type of Organization: <
Private
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Industry: <
Medical Devices
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Key Executives: <
CEO: Rene van de Zande
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COO: Michael van der Woude
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Public Relations <
Contact: <
Chris Schorre
Phone: <
1-512-327-9997
Email: <
cs@emergogroup.com
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