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FDA ACCREDITS 15 THIRD PARTIES FOR QSR INSPECTIONS
The FDA
has accredited 15 third parties for FDA QSR inspections. The list of
these third parties appears below.
The accredited third parties are not for everyone, and
unlike the FDA inspectors, will charge a fee for the inspection.
There are some rigid manufacturer eligibility requirements and in order for the
program to be advantageous to most manufacturers, you have to propose an
inspection by an accredited third party PRIOR to the FDA inspector giving you a
call to tell you "they'll be in the area next week."
For more information on the third party program, and a
no-cost, no obligation assessment of whether or not the third party program may
be good for your company, click here.
The list of 15 Accredited Third Parties (from
the FDA
website) are:
| 1. |
Firm Name: AMTAC Certification Services Limited
Address: Norman Road, Broadheath, Altrincham
City, State: Cheshire, England
Country: United Kingdom
Contact Name: Mr. David Gale
Phone: +44 (0) 161 928 8924
Fax: + 44 (0) 161 927 7359
Email: acsl@amtac.co.uk
Foreign Certification/Recognition: United Kingdom, Canada
Types of Devices: All Medical Devices |
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| 2. |
Firm Name: BSI, Inc.
Address: 12110 Sunset Hills Road, Suite 140
City, State: Reston, Virginia 20190 - 3231
Country: USA
Contact Name: Mr. Paul Brooks
Phone: +1 (703) 437-9000
Fax: +1 (703) 437-9001
Email: paul.brooks@bsiamericas.com
Foreign Certification/Recognition: United Kingdom, Canada
Types of Devices: All Medical Devices |
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| 3. |
Firm Name: Danish Medical Devices Certification (DGM)
Address: Kollegievej 6
City, State: DK-2920 Charlottenlund
Country: Denmark
Contact Name: Ms. Anne Klitgård
Phone: +45 3996 6400
Fax: +45 3996 6401
Email: akl@ds.dk
Foreign Certification/Recognition: Denmark
Types of Devices: All Medical Devices |
| 4. |
Firm Name: DQS GmbH
Address: August Schanz Strasse 21
City, State: 60433 Frankfurt
Country: Germany
Contact Name: Mr. Hans Peter Bonifer
Phone: +49 (0) 69-95427-372
Fax: +49 (0) 69-95427-372
Email: Hans-peter.bonifer@dqs.de
Foreign Certification/Recognition: Germany, Canada
Types of Devices: All Medical Devices |
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| 5. |
Firm Name: Entela, Inc.
Address: 3033 Madison Ave, SE
City, State: Grand Rapids, Michigan 49548
Country: USA
Contact Name: Mr. Nick Maalouf
Phone: (416) 241-8427
Fax: (416) 241-0682
Email: nmaalouf@entela.com
Foreign Certification/Recognition: Canada
Types of Devices: Electro-medical devices only |
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| 6. |
Firm Name: G-MED
Address: 33, avenue du General Leclerc, P.O. Box: 8
City, State: 92260 FONTENAY-AUX-ROSES, Hauts-de-Seine
Country: France
Contact Name: Mr. Bernard Lambert
Phone: +33 1-40-95-63-54
Fax: +33-1-40-95-63-22
Email: Bernard.lambert@gmed.fr
Foreign Certification/Recognition: France, Canada
Types of Devices: All Medical Devices |
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| 7. |
Firm Name: Intertek Testing Services NA, Inc.
Address: 70 Codman Hill Road
City, State: Boxborough, Massachusetts 01719
Country: USA
Contact Name: Ms. Christine Forcier
Phone: (905) 678-7820, ext. 263
Fax: (978) 635-8595
Email:
Christine.forcier@intertek.com
Foreign Certification/Recognition: Netherlands, Canada, Sweden
Types of Devices: All Medical Devices, except IVDs and Neurological
Devices |
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| 8. |
Firm Name: Center for Measurement Standards/Industrial
Technology Research Institute (CMS/ITRI)
Address: Bldg. 16, 321 Kuang Fu Rd., Sec. 2
City, State: Hsinchu, Taiwan 30042
Country: Republic of China
Contact Name: Mr. Tzu-Wei Li
Phone: +886 3 573 227
Fax: +886 3 573 299
Email:
alberttwli@itri.org.tw
Foreign Certification/Recognition: USA, Taiwan, Germany
Types of Devices: All Medical Devices |
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| 9. |
Firm Name: KEMA Quality B.V.
Address: Utrechtseweg 310
City, State: 6812 Arnhem
Country: The Netherlands
Contact Name: Ir. J.H. van Lochem MBM
Phone: +31 61 506 3680
Fax: +31 26 3 5156 06
Email: jan.vanlochem@kema.com
Foreign Certification/Recognition: Netherlands, Canada
Types of Devices: All Medical Devices |
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| 10. |
Firm Name: Orion Registrar, Inc.
Address: 7850 Vance Drive, Suite 210
City, State: Arvada, Colorado 80003
Country: USA
Contact Name: Mr. Paul Burck
Phone: (303) 456-6010
Fax: (303) 456-6681
Email:
pburck@orion4value.com
Foreign Certification/Recognition: Canada
Types of Devices: All Medical Devices |
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| 11. |
Firm Name: Quality Management Institute (QMI)
Address: 90 Burnhamthorpe Rd. W., Suite 300
City, State: Mississauga, Ontario L5B 3C3
Country: Canada
Contact Name: Ms. Josee Adam
Phone: (514) 428-2490
Fax: (514) 694-9697
Email: jadam@qmi.com
Foreign Certification/Recognition: Canada, Netherlands, Mexico
Types of Devices: All Medical Devices, except Immunology,
Microbiology, Neurological, and OB-GYN Devices |
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| 12. |
Firm Name: QS Zürich AG
Address: Wehntalerstrasse, PO Box 211
City, State: CH 8057 Zürich
Country: Switzerland
Contact Name: Mr. Eugen Moor
Phone: +49 1 350 46 65
Fax: +49 1 350 46 69
Email:
quality-service@magnet.ch
Foreign Certification/Recognition: Switzerland
Types of Devices: All Medical Devices, except IVDs |
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| 13. |
Firm Name: SGS United Kingdom Limited
Address: 202B Worle Parkway
City, State: Weston-super-Mare, BS22-6WA
Country: United Kingdom
Contact Name: Mr. Christopher Jepson
Phone: +44 1934 522917
Fax: +44 1934 522137
Email: Chris_Jepson@sgs.com
Foreign Certification/Recognition: Canada, United Kingdom
Types of Devices: All Medical Devices |
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| 14. |
Firm Name: TUV America, Inc.
Address: 5 Cherry Hill Drive
City, State: Danvers, Massachusetts 01923
Country: USA
Contact Name: Mr. Gregor Dzialas
Phone: +1 (978) 739-7028
Fax: +1 (978) 774-9987
Email: gdzialas@tuvam.com
Foreign Certification/Recognition: Canada
Types of Devices: All Medical Devices |
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| 15. |
Firm Name: TUV Rheinland of North America, Inc.
Address: 1279 Quarry Lane, Suite A
City, State: Pleasanton, CA 94566
Country: USA
Contact Name: Mr. Heinz Joerg Steneberg
Phone: (925) 249-9123, ext. 111
Fax: (925) 249-9124
Email: hsteneberg@us.tuv.com
Foreign Certification/Recognition: Canada
Types of Devices: All Medical Devices |
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