Request a Quotation Estimate
Please provide all required information to receive a preliminary quote. We will reach out with any questions or concerns.
Kindly contact
medaudit@us.tuv.com
with any immediate questions or concerns.
First Name
*
Last Name
*
Legal Company Name
*
E-Mail
*
Phone
*
Street
*
House Number
ZIP
*
City
*
State or Province
-- please select --
Alberta
Alabama
Alaska
American Samoa
Arizona
Arkansas
British Columbia
California
Colorado
Connecticut
Delaware
District of Columbia
Florida
Georgia
Guam
Hawaii
Iowa
Idaho
Illinois
Indiana
Kansas
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Louisiana
Massachusetts
Manitoba
Maryland
Maine
Michigan
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Northern Mariana Islands
Mississippi
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South Carolina
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Saskatchewan
Tennessee
Texas
Utah
Virginia
Virgin Islands
Vermont
Washington
West Virginia
Wisconsin
Wyoming
Yukon
Outside province/Can
Scheme(s) Requested
*
EN ISO 13485:2016 (DAkkS)
MDSAP
MDR
IVDR
Activities Excluded
*
Production
Design & Development
Not Applicable
MDSAP Jurisdictions
Australia (TGA)
Brazil (Anvisa)
Canada (Health Canada)
Japan (MHLW/PMDA)
USA (FDA)
Number of full-time employees (FTE) in particular departments:
Quality Management
Design
Manufacturing
Distribution
Service
Administration
Sales
Other
Details about Technologies applicable for your QMS/device(s):
*
Devices manufactured using metal processing (MDT/IVT 2001)
Devices manufactured using plastic processing (MDT/IVT 2002)
Devices manufactured using non-metal mineral processing (MDT/IVT 2003)
Devices manufactured using non-metal non-mineral processing (MDT/IVT 2004)
Devices manufactured using biotechnology (MDT/IVT 2005)
Devices manufactured using chemical processing (MDT/IVT 2006)
Devices which require knowledge regarding the production of pharmaceuticals (MDT/IVT 2007)
Devices manufactured in clean rooms and associated controlled environments (MDT/IVT 2008)
Devices manuf. using processing of materials of human, animal, or microbial origin (MDT/IVT 2009)
Devices manufactured using electronic components including communication devices (MDT/IVT 2010)
Devices which require packaging, including labelling (MDT/IVT 2011)
Devices which require installation, refurbishment (MDT 2012)
Devices which have undergone reprocessing (MDR 2013)
Hover over each option above for additional information about your device.
Do you currently hold a certificate with another Certification Body / Notified Body?
*
Yes
No
Who and for what schemes (ISO 13485, MDR, etc)
Did you receive consultancy regarding the implementation of your QMS?
Please provide details on your outsourced processes. Put N/A if this is not applicable.
Design & Development, Purchasing, Production, Warehouse, Sales, Service
Any additional information or questions:
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