TestLabIndex

FDA ASCA medical device testing

Laboratories accredited under FDA's Accreditation Scheme for Conformity Assessment for premarket device testing programs. Source: ASCA-accredited testing laboratories database (U.S. Food and Drug Administration), retrieved July 2026.

Standards under this scheme (2)

Laboratories (57)

#LaboratoryLocationRegistry accreditationsStandards
1 Nelson Laboratories, LLC Ontario, California, United States 5 1
2 Nemko USA, Inc. Carlsbad, California, United States 5 1
3 DLS Electronic Systems, Inc. Wheeling, Illinois, United States 4 1
4 DEKRA Certification, Inc. Sterling, Virginia, United States 3 118
5 Element Materials Technology Irvine Irvine, California, United States 3 1
6 Element Materials Technology Portland - Evergreen Inc. Irvine, California, United States 2 21
7 TUV SUD CANADA, INC. Kanata, ON, Canada 2 1
8 Washington Laboratories, Ltd. Frederick, Maryland, United States 2 1
9 3M Company, Hardgoods Regulatory Laboratory (HRE) Minnesota, United States 1 1
10 Acertara Acoustic Laboratories LLC Colorado, United States 1 1
11 Compatible Electronics, Inc. - Brea California, United States 1 1
12 Compatible Electronics, Inc. - Lake Forest California, United States 1 1
13 Compatible Electronics, Inc. - Newbury Park California, United States 1 1
14 Cook Research Incorporated Indiana, United States 1 1
15 Criterion, a Biotex, Inc. service Texas, United States 1 1
16 CSA America Testing & Certification LLC - Irvine California, United States 1 1
17 CSA Group Testing & Certification Inc. - Toronto Canada 1 1
18 Element Materials Technology Dallas-Plano West Texas, United States 1 1
19 Element Materials Technology Minneapolis - Brooklyn Park Oregon, United States 1 1
20 Element Materials Technology Seattle-Bothell 120th Washington, United States 1 1
21 Eurofins Electrical & Electronic Testing NA, Inc. (Eurofins E&E) dba CertifiGroup North Carolina, United States 1 1
22 EUROFINS ELECTRICAL AND ELECTRONIC TESTING NA, INC. - Santa Clara California, United States 1 1
23 Eurofins Electrical and Electronic Testing NA, LLC - Austin Texas, United States 1 1
24 Eurofins Electrical and Electronic Testing NA, LLC - Baltimore Maryland, United States 1 1
25 EUROFINS ELECTRICAL AND ELECTRONIC TESTING NA, LLC. - Irvine California, United States 1 1
26 F2 Labs - Maryland Maryland, United States 1 1
27 F2 Labs - Ohio Ohio, United States 1 1
28 HCT America, Inc. California, United States 1 1
29 Intertek Testing Services NA, Inc. - Boxborough Massachusetts, United States 1 1
30 Intertek Testing Services NA, Inc. - Duluth Georgia, United States 1 1
31 Intertek Testing Services NA, Inc. - Fridley Minnesota, United States 1 1
32 Intertek Testing Services NA, Inc. - Lake Forest California, United States 1 1
33 Intertek Testing Services NA, Inc. - Lexington Kentucky, United States 1 1
34 Intertek Testing Services NA, Inc. - Menlo Park California, United States 1 1
35 Intertek Testing Services NA, Inc. - Plano Texas, United States 1 1
36 Intertek Testing Services, NA, Inc. Skaneateles New York, United States 1 1
37 Medical Engineering & Development Institute Incorporated dba MED Institute Indiana, United States 1 1
38 Medical Equipment Compliance Associates, LLC Wisconsin, United States 1 1
39 MEDTRONIC PLC. (RELIABILITY ASSURANCE & DESIGN ASSURANCE LABORATORIES) Minnesota, United States 1 1
40 Nemko USA Inc. (Austin TL) Texas, United States 1 1
41 North American Science Associates (NAMSA) Ohio, United States 1 1
42 Product Safety Labs, LLC New Jersey, United States 1 1
43 Retlif Testing Laboratories - New York New York, United States 1 1
44 Retlif Testing Laboratories - Pennsylvania Pennsylvania, United States 1 1
45 SIGMA SCIENTIFIC SERVICES LLC Florida, United States 1 1
46 Timco Engineering, Inc., an IIA Company Florida, United States 1 1
47 TUV Rheinland North America, Inc - Boxborough Massachusetts, United States 1 1
48 TUV SUD America, Inc. - New Brighton Minnesota, United States 1 1
49 TUV SUD America, Inc. - San Diego California, United States 1 1
50 TÜV Rheinland of North America, Inc. - Pleasanton California, United States 1 1
51 UL LLC - Fremont California, United States 1 1
52 UL LLC - Mounds View Minnesota, United States 1 1
53 UL LLC - Northbrook California, United States 1 1
54 UL LLC - Northbrook EMC Illinois, United States 1 1
55 UL LLC - Research Triangle Park North Carolina, United States 1 1
56 UL LLC - Research Triangle Park EMC Lab North Carolina, United States 1 1
57 UL Verification Services, Inc. (Fremont - EMC Lab) California, United States 1 1

Ranked by published objective criteria — see methodology.