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
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.