Business Services Industry
Company Profile for Emergo Group, Inc
Business Wire, June 13, 2008
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 quality system implementation, auditing and training, Form 483 and Warning Letter recovery, ISO 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 compliance, MHLW Ordinance #169 consulting, Seihin Hyojun Sho file creation, reimbursement consulting and STED preparation.
* CHINA: SFDA medical device approvals, Legal Agent and After Sales Agent representation, CCC 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: <
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