Global Facilities

Facility square footage: 136,400 ft2 (12.670 m2)

Certifications, Registrations, and Compliance: ISO 9001, ISO 14001 and IATF/TS 16949 certification

Facility square footage: 220,000 ft2 (20.438 m2)

Certifications & Regulations: ISO 14001, ISO 13485, IATF 16949, and ISO 9001

Facility square footage: 382,000 ft2 (35.489 m2)

Certifications, Registrations, and Compliance: ISO 9001, ISO 14001, IATF/TS 16949, ISO 13485 compliant

Facility square footage: 220,000 ft2 (20.438 m2)

Facility square footage: 70,000 ft2 (6.500 m2)

Certifications, Registrations, and Compliance: ISO 13485 (with design), 21 CFR 820, MHLW

Facility square footage: 185,000 ft2 (17.187 m2)

Certifications, Registrations, and Compliance: ISO 13485, ISO 9001, ISO 14001 and IATF/TS 16949 certification

Facility square footage: 185,000 ft2 (17.187 m2)

Certifications, Registrations, and Compliance: ISO 13485, ISO 9001, ISO 14001 and IATF/TS 16949 certification

Facility square footage: 136,400 ft2 (12.670 m2)

Certifications, Registrations, and Compliance: ISO 13485, ISO 14001 and IATF/TS 16949 certification

Facility square footage: 69,000 ft2 (6.410 m2)

Certifications, Registrations, and Compliance: ISO 13485 certification (with design)

Facility square footage: 3,000 ft2 (280 m2)

Certifications, Registrations, and Compliance: ISO 13485 certification (with design)

Facility square footage: 55,000 ft2 (5.110 m2)

Certifications, Registrations, and Compliance: ISO 13485

Facility square footage: 118,000 ft2 (10.960 m2)

Certifications, Registrations, and Compliance: ISO 14001 and IATF/TS 16949 certification

Facility square footage:  264,440 ft2 (24.570 m2)

Certifications, Registrations, and Compliance: ISO 13485, Medical Device 21 CFR 820 compliant (registered), 21 CFR 210/211 compliant (registered), Combo 21 CFR 4 compliant, ISO 14001

Facility square footage: 264,440 ft2 (24.570 m2)

Certifications, Registrations, and Compliance: ISO 13485, Medical Device 21 CFR 820 compliant (registered), 21 CFR 210/211 compliant (registered), Combo 21 CFR 4 compliant, ISO 14001

Facility square footage: 264,440 ft2 (24.570 m2)

Facility square footage: 264,440 ft2 (24.570 m2)

Certifications, Registrations, and Compliance: ISO 13485

Facility square footage: 264,440 ft2 (24.570 m2)

Certifications, Registrations, and Compliance: : ISO 9001, ISO 14001 and IATF/TS 16949 certification

Facility square footage: 161,000 ft2 (15.000 m2)

Facility square footage: 161,000 ft2 (15.000 m2)

Facility square footage: 136,400 ft2 (12.670 m2)

Certifications, Registrations, and Compliance: ISO 13485

Facility square footage: 144,000 ft2 (13.380 m2)

Certifications, Registrations, and Compliance: ISO 13485, Medical Device 21 CFR 820 compliant (registered), Medical Device MHLW compliant and ISO 14001

Facility square footage: 110,000 ft2 (10.220 m2)

Certifications, Registrations, and Compliance: ISO 13485 (with design), Medical Device 21 CFR 820 compliant and Medical Device MHLW compliant

Facility square footage: 110,000 ft2 (10.220 m2)

Certifications, Registrations, and Compliance: ISO 13485 and ISO 9001

Facility square footage: 45,870 ft2 (4.260 m2)

Certifications, Registrations, and Compliance: ISO 13485, ISO 9001, Medical Device 21 CGR 820 compliant (registered) and ISO 14001

Medical devices development, prototyping, and testing facility

Facility square footage: 41,441 ft2 (3.850 m2)

Facility square footage: 287,400 ft2 (26.700 m2) - two facilities

Certifications, Registrations, and Compliance: : ISO 13485 (with design), Medical Device 21 CFR 820 compliant, MDD 93/42 compliant and ISO 14001

Facility square footage: 287,400 ft2 (26.700 m2) - two facilities

Facility square footage: 2000 ft2 (168m2)

Facility square footage: 6458,346 ft2 (600 m2)

Certifications, Registrations, and Compliance: ISO 13485, ISO 15378 compliant, Medical Device 21 CFR 820 compliant (registered), Medical Device MHLW compliant and MDD 93/42 compliant

Facility square footage: 97,951 ft2 (9.100 m2)

Certifications, Registrations, and Compliance: ISO 13485, ISO 15378 compliant, Medical Device 21 CFR 820 compliant (registered), MDD 93/42 compliant and ISO 14001.

Facility square footage: 90,560 ft2 (8400 m2)

Certification, Registration, and Compliance: EN ISO 13485:2016 certification
MDSAP certification according to ISO 13485:2016 and the requirements of the United-States, Canada, Australia, and Japan
Medical Device Directive (93/42/EEC) Annex II certificate
ISO 14001:2015 compliance

Facility square footage: Facility square footage: 485,000 ft2 (45.057 m2)

Facility square footage: 164,900 ft2 (15.320 m2)

Certifications & Regulations: ISO 13485 (with design), Medical Device 21 CFR 820 compliant and Medical Device GMP NMPA compliant

Facility square footage: 164,900 ft2 (15.320 m2)

Facility square footage: 164,900 ft2 (15.320 m2)

Certifications & Regulations: ISO 9001 (Dec ’18) and ISO 13485 compliance

Facility square footage: 44,100 ft2 (4.097 m2)

Certifications & Regulations: ISO 13485, ISO 9001, Medical Device 21 CFR 820 compliant, ISO 14001 and OHSAS 18001