Your comprehensive resource for FDA-recognized testing facilities
Welcome to our curated directory of ASCA-accredited testing laboratories. These elite facilities are officially recognized under the FDA's ASCA Pilot Program for their excellence in medical device testing according to FDA-recognized standards.
Each laboratory in our directory has demonstrated exceptional expertise in conducting comprehensive tests for basic safety and essential performance of medical devices, facilitating a more efficient path to FDA compliance for manufacturers.
12 LABORATORY DRIVE RESEARCH TRIANGLE PARK NC 27709 US
Basic safety and essential performance
Michael Keeler
66 Hatachana St. POB 23 Binyamina 3055001 IL
Basic safety and essential performance
George Shleimovich
18F. No.716 Zhongzheng Rd. Zhonghe Dist. 235 New Taipei City TW
Basic safety and essential performance
Ken Wang
Room 401 4FBlock C Building 1 No.139JingHai 3rd Road Economic Technological Development Area Beijing 100176 CN
Basic safety and essential performance
Jingming Zhao
313 W 12800 S Suite 311 Draper UT 84020 US
Basic safety and essential performance
Jason Stewart
4383-326 ASAMA-CHO ISE-SHI MIE-KEN 516-0021 JP
Basic safety and essential performance
Pamela Gwynn
Torshamngatan 43 Stockholm 16440 SE
Basic safety and essential performance
Yaqing Liu
1283 Yadoriki Matsuda Ashigarakami-gun Kanagawa 258-0001 JP
Basic safety and essential performance
Yaqing Liu
298-6 Sada Kashima Ibaraki 314-0027 JP
Basic safety and essential performance
Yaqing Liu
Via delle Industrie 5&6 20061 Carugate (MI) Carugate 20061 IT
Basic safety and essential performance
Pamela Gwynn
Via Felice Matteucci Calenzano 10 50041 IT
Basic safety and essential performance
Lorenzo Spinelli
4383-326 Asama-cho Ise-shi Mie 516-0021 Mie JP
Basic safety and essential performance
Masanori Nishiyama
1250 Peterson Drive Wheeling IL 60090 US
Basic safety and essential performance
Mitch Gaudyn
901 Sheldon Drive Unit B Cary NC 27513 US
Basic safety and essential performance
Bill Bisenius
RÓWNOLEGLA 4 WARSZAWA 02-235 REPUBLIC OF POLAND PL
Basic safety and essential performance
Pamela Gwynn
Admiral Rosendahl Strasse 23 Neu Isenburg 62263 DE
Basic safety and essential performance
Pamela Gwynn
10 Technology Dr Unit B Peabody MA 01960 US
Basic safety and essential performance
141 14th St NW New Brighton MN 55112 US
Basic safety and essential performance
William Elliott
5610 West Sligh Ave Ste 100 Tampa FL 33634 Tampa FL 33634 US
Basic safety and essential performance
William Elliott
10040 Mesa Rim Rd San Diego CA 92121 US
Basic safety and essential performance
William Elliott
11 Gordon Collins Dr Gormley Ontario L0H 1G0 Ontario CA
Basic safety and essential performance
William Elliott
1 Geddes Way Unit B West Lafayette IN 47906 US
Basic safety and essential performance
Ray Boudreaux
26501 Ridge Rd. Unit B Damascus MD 20872 US
Basic safety and essential performance
Ken Littell
16740 Peters Rd. Middlefield Unit B Damascus MD 20872 US
Basic safety and essential performance
Ken Littell
3 Ha'oreg Street Modi'in 7177909 IL
Basic safety and essential performance
Ilan Cohen
1285 WALT WHITMAN ROAD Unit B MELVILLE NE 11747 US
Basic safety and essential performance
Pamela Gwynn
2222 WOODALE DRIVE SUITE 300 MOUNDS VIEW MN 55112 US
Basic safety and essential performance
Pamela Gwynn
140 E. Rawson Ave Suite 301 Oak Creek WI 53154 US
Basic safety and essential performance
Alex Grob
C/ Monturiol 15 28906 Getafe Madrid ES
Basic safety and essential performance
Miguel Martinez
47173 Benicia Street Fremont CA 94538 US
Basic safety and essential performance
Pamela Gwynn
545 E. Algonquin Road Arlington Heights IL 60005 US
Basic safety and essential performance
Yaqing Liu
70 Codman Hill Road Boxborough MA 01719 US
Basic safety and essential performance
Yaqing Liu
1950 Evergreen Boulevard Suite 100 Duluth GA 30096 US
Basic safety and essential performance
Yaqing Liu
4700 Broadmoor SE Suite 200 Kentwood MI 49512 US
Basic safety and essential performance
Yaqing Liu
25800 Commercentre Drive Suite 200 Lake Forest CA 92630 US
Basic safety and essential performance
Yaqing Liu
731 Enterprise Drive Lexington KY 40510 US
Basic safety and essential performance
Yaqing Liu
1365 Adams Court Suite 200 Menlo Park CA 94025 US
Basic safety and essential performance
Yaqing Liu
40 51st Way NE Suite 100 Fridley MN 55421 US
Basic safety and essential performance
Yaqing Liu
1809 10th Street Suite 400 Plano TX 75074 US
Basic safety and essential performance
Yaqing Liu
1198 Qinzhou Road North Bldg. No. 86 Shanghai 200233 CN
Basic safety and essential performance
Yaqing Liu
Yasuda Shibaura No.2 Bldg. 4F 3-2-12 Kaigan Minato-ku Tokyo 108-0022 JP
Basic safety and essential performance
Yaqing Liu
Via Principe di Udine 114 Campoformido Udine 33030 IT
Basic safety and essential performance
Yaqing Liu
849 NW State Road 45 Suite 400 Newberry FL 32699 US
Basic safety and essential performance
Daniel Sigouin
2210 Faraday Ave Suite 150 Carlsbad CA 92008 US
Basic safety and essential performance
Jan Robert Blomgren
2210 Faraday Ave Suite 150 Carlsbad CA 92008 US
Basic safety and essential performance
Jan Robert Blomgren
13501 McCallen Pass Suite 150 Austin TX 78753 US
Basic safety and essential performance
Sandi Mullins
914 West Patapsco Avenue Suite 150 Baltimore MD 21230 US
Basic safety and essential performance
Sandi Mullins
33439 Western Avenue Suite 150 Union City CA 94587 US
Basic safety and essential performance
Sandi Mullins
34 Bunsen Suite 150 Irvine CA 92618 US
Basic safety and essential performance
John Sena
5-40-6 Koishikawa Tokyo 112-0002 JP
Basic safety and essential performance
John Sena
865 Ellingham Avenue Pointe-Claire Quebec H9R5E8 CA
Basic safety and essential performance
John Sena
13799 Commerce Parkway Richmond British Columbia V6V 2N9 CA
Basic safety and essential performance
John Sena
178 Rexdale Blvd. Toronto ON Toronto M9W 1R3 CA
Basic safety and essential performance
John Sena
52 Chungmin-Ro Songpa-Gu Seoul 05839 Republic of Korea Seoul KR
Basic safety and essential performance
John Sena
Floor1 Bldg. 4 889 Yishan Road Qilai Industrial City Shanghai CN
Basic safety and essential performance
John Sena
3801 E. Plano Pkwy Suite 150 Plano TX 75074 US
Basic safety and essential performance
Renee Walker
41 Tesla Ave Suite 150 Irvine CA 92618 US
Basic safety and essential performance
Renee Walker
6775 NE Evergreen Parkway Suite 400 Portland OR 97124 US
Basic safety and essential performance
Renee Walker
9349 W Broadway Ave. Brooklyn Park Suite 400 Portland OR 97124 US
Basic safety and essential performance
Renee Walker
6750 Wales Road Suite 400 Northwood OH 43619 US
Biocompatibility
Austin Zdawczyk
3000 Minuteman Road Suite 400 Andover MA 01810 US
Basic safety and essential performance
Leonard Kay
No. 7-2 Chapin Road Science City GETDD Guanzhou Guangdong Province Guanzhou 510663 CN
Basic safety and essential performance
Yaqing Liu
1279 Quarry Lane Suite A Pleasanton CA 94566 US
Basic safety and essential performance
Richard Decker
1950 Lefthand Creek Lane Longmont CO 80501 US
Basic safety and essential performance
Callie Moore
405 Glenn Dr. Suite 11&12 Building 199 Sterling VA 20164 US
Basic safety and essential performance
Domingo Gálvez
19201 120th Ave. NE Suite 104 Bothell WA 98011 US
Basic safety and essential performance
Renee Walker
Building 10 Innovation Technology Park Song Shan Lake Hi tech Development Zone Dongguan 523808 CN
Basic safety and essential performance
Summer Xiao
1075 West Lambert Road Unit B Brea CA 92821 US
Basic safety and essential performance
Pamela Gwynn
3M Center Building 220-6E-E04 St. Paul MN 55144-1000 US
Basic safety and essential performance
Yuriy Litvinov
101 New Boston Road Building 220-6E-E04 Goffstown 03045 US
Basic safety and essential performance
Scott Wentworth
795 Marconi Avenue Building 220-6E-E04 Ronkonkoma NY 11779 US
Basic safety and essential performance
Robert Bernius
3131 Detwiler Road Building 220-6E-E04 Harleysville PA 19438 US
Basic safety and essential performance
Richard Reitz
ELECTRONIC BUILDING PARAGE ELECTRONIC INDUSTRIAL PARK NO.8 NANYUN ER ROAD GUANGZHOU SCIENCE PARK GUANGZHOU 510670 CN
Basic safety and essential performance
Pamela Gwynn
NO. 2 CHENGWAN ROAD SUZHOU INDUSTRIAL PARK PEOPLES REPUBLIC OF CHINA SUZHOU 215122 CN
Basic safety and essential performance
Pamela Gwynn
No. 198 of Kezhu Road Science Park Guangzhou Economic & Technology Development District Guangzhou Guangdong CN
Basic safety and essential performance
Bonnie Liao
Building C Hongwei Industrial Park Block 70 Bao'an District Guangdong Peoples Republic of China Shenzhen 518101 CN
Basic safety and essential performance
Robin Zhang
1330 Win Hentschel Blvd. Ste. 100 Building 220-6E-E04 West Lafayette IN 47906 US
Basic safety and essential performance
Colleen Tennyson
333 Pfingsten Rd. Northbrook Unit B Brea CA 92821 US
Basic safety and essential performance
Pamela Gwynn
114 Olinda Drive Brea CA 92823 US
Basic safety and essential performance
Kyle Fujimoto
20621 Pascal Way Lake Forest CA 92630 US
Basic safety and essential performance
Michael Clark
1050 Lawrence Drive Newbury Park CA 91320 US
Basic safety and essential performance
Ruby Hall
4840 Winchester Blvd. Ste 5 Frederick MD 91320 US
Basic safety and essential performance
Steven Koster
15 International Business Park TUV SUD @ IBP Singapore 609937 SG
Basic safety and essential performance
Xin Pei Kee
No 12Pulong East 1st Road Tangxia Town DongguanPeoples Republic of China Guangdong 523719 CN
Basic safety and essential performance
Laura Cortes
333 Pfingston Rd. Northbrook IL 60062 US
Basic safety and essential performance
Michael Keeler
42 Chaim Levanon Street Tel Aviv 69977 IL
Basic safety and essential performance
Irina Antonov
12 Laboratory Drive Unit B Research Triangle Park NC 27709 US
Basic safety and essential performance
Pamela Gwynn
No. 588 West Jindu Road Xinqiao Songjiang Shanghai 201612 CN
Basic safety and essential performance
Sally Shi
1~6/F 260 DA-YEH ROAD 1ST 2ND 4TH 5TH 6TH FLOOR 35 SEC. 2 CHUNGYANG S. ROAD 112 TAIWAN REPUBLIC OF CHINA PEITOUTAIPEI CITY TW
Basic safety and essential performance
Pamela Gwynn
490 Sawgrass Corporate Parkway Suite 130 Sunrise FL 33325 US
Basic safety and essential performance
Jorge Millan
11F. No. 758 Sec. 4 Bade Rd. Songshan Dist. Taipei 105 Taiwan Taipei TW
Basic safety and essential performance
Jon Lin
Shanghai TÜV Rheinland Building 1/F. of No.10 No.153/165/177/178/179/182/189/192/198 Lane 777 Guangzhong West Road Jing¿an District Shanghai People's Republic of China 200072 Shanghai CN
Basic safety and essential performance
Audrey Zhao
6280 S Redwood Road Building 199 Salt Lake City UT 84123 US
Biocompatibility
James Porch
NF Park Bldg 4F 2-9-15 Futaba Shinagawa-ku Tokyo 142-0043 JP
Basic safety and essential performance
Toshiyuki Tamori
1601-1604 17-18F Tower A Building 2 Shenzhen International Innovation Valley Dashi 1st Road Xili Street Xili Community Nanshan District Shenzhen 518052 CN
Basic safety and essential performance
Gina Yang
No.140-1 Changan St. Bade District Taoyuan City 334025 TW
Basic safety and essential performance
Misty Wu
Via Bruno Buozzi 2 20055 VIMODRONE (MI) VIMODRONE IT
Biocompatibility
Francesca Salvatori
No. 818 Wusong Road Wuzhong District Suzhou Jiangsu 215124 CN
Biocompatibility
Shirley Chan
2540 Executive Drive St. Paul MN 55120 US
Biocompatibility
Ben Steiner
20097 San Donato Milanese (MI) Milano IT
Basic safety and essential performance
Alessandro Melzi
Block 5 No.3 Qiyun Road Huangpu District Guangzhou Guangdong CN
Basic safety and essential performance
Johnson Liu
3162 Belick Street Santa Clara CA 95054 US
Basic safety and essential performance
Greg Kovolenko
47173 BENICIA STREET Fremont CA 94538 US
Basic safety and essential performance
Michael Keeler
7000 Central Ave NE Fridley MN 55432 US
Basic safety and essential performance
Michael Simpeh SR
Building 18 No. 2168 Chenghang Highway Minhang District Shanghai CN
Basic safety and essential performance
June Fan
32 Mauchly Suite A Irvine CA 92618 US
Basic safety and essential performance
Greg Kovolenko
114 Holmes Rd. Houston TX 77045 US
Basic safety and essential performance
Nathan Slota
1601 N. A.W. Grimes Blvd. Suite B Round Rock TX 78665 US
Basic safety and essential performance
Jan Blomgren
4341 State Street Suite 100 Skaneateles Falls NY 13153 US
Basic safety and essential performance
Yaqing Liu
74 Seoicheon-ro 578beongil Majang-myeon Gyeonggi Provence Icheon City Gyeonggi Provence KR
Basic safety and essential performance
Monica No
One Distribution Center Circle Suite #1 Littleton MA 01460 US
Basic safety and essential performance
Elizabeth Casey
D1 Building No.63 Chuangqi Road Shilou Panyu District Guangzhou CN
Basic safety and essential performance
Vivian Li
726 Ringwood Ave San Jose CA 95131 US
Basic safety and essential performance
Sunwoo Kim
1701 E. Plano Parkway Suite 150 Plano TX 75074 US
Basic safety and essential performance
Louie Bustillos
Currently displaying 114 ASCA-accredited testing laboratories
Last updated: November 29, 2024 | Accreditation status verified through FDA ASCA Pilot Program
ASCA (Accreditation Scheme for Conformity Assessment) is an FDA pilot program designed to enhance consistency and predictability in the FDA's approach to assessing conformity with FDA-recognized consensus standards and test methods.
Working with ASCA-accredited laboratories provides enhanced confidence in testing results, potentially faster FDA review of premarket submissions, and consistent, high-quality testing for medical device manufacturers.
ASCA laboratories specialize in comprehensive testing for basic safety and essential performance of medical devices, including biocompatibility testing and specialized safety/performance testing for various device categories.
Selecting the right ASCA-accredited laboratory involves considering their specific accreditation scope, device type expertise, and location. We've included detailed profiles to help guide your decision-making process.