ISO 13485 certified medical devices companies in Mexico

Medical devices manufacturers whose own websites show ISO 13485 certification.We list 18 ISO 13485 medical devices manufacturers across Mexico. 18 have researched profiles with capabilities quoted from their own websites, and 16 are confirmed to take outside orders.

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Top 18 of 18

Researched profiles first, then by size · Updated October 14, 2026

ANA de Mexico
Tijuana, Baja California·251+ employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
- ✓ISO 14001
- ✓ISO 9001
“ISO 13485, ISO 9001, and ISO 14001 certifications—the quality systems regulated industries build their audits around.”
ana-global.comTakes outside ordersProfile →
Rogers Foam Tijuana
Tijuana, Baja California·251+ employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
“Tijuana, BC México – ISO 13485”
rogersfoam.comTakes outside ordersProfile →
Westfall Technik
Tijuana, Baja California·251+ employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
“ISO 13485: 2016 Registrar Intertek”
westfalltechnik.comTakes outside ordersProfile →
Manufactura Integrada del Pacifico
Tijuana, Baja California·251+ employees·Contract manufacturer
- ✓ISO 13485
- ✓FDA registered
- ✓ISO 13485
“As an ISO 13485-certified and FDA registered company, we offer turnkey solutions with corporate headquarters in San Diego and production facilities in Tijuana.”
pacific-im.comTakes outside ordersProfile →
Acon LAB
Tijuana, Baja California·251+ employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
“ISO 13485:2016 Certified”
aconlabs.comTakes outside ordersProfile →
JB Tecnics Mexico
El Marqués, Querétaro·101–250 employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
“ISO 7, ISO 8, ISO 9001, ISO 13485, ISO 15378, BPF.”
groupejbt.comTakes outside ordersProfile →
Industrias Plasticas Medicas
Ayala, Morelos·101–250 employees·Contract manufacturer
- ✓ISO 13485
- ✓FDA registered
- ✓ISO 13485
“ISO 13485 y registro ante FDA.”
ipm.mxTakes outside ordersProfile →
Coastline de Mexico
Tijuana, Baja California·101–250 employees·Contract manufacturer
- ✓ISO 13485
- ✓FDA registered
- ✓ISO 13485
- ✓ISO 9001
“All manufacturing operations are ISO 13485 ISO 9001 certified and FDA registered.”
coastlineintl.comTakes outside ordersProfile →
Inventus Power Mexico
Tijuana, Baja California·101–250 employees·Contract manufacturer
- ✓ISO 13485
- ✓C-TPAT
- ✓ISO 13485
- ✓ISO 14001
- ✓ISO 9001
“ISO: 13485: 2016”
inventuspower.comTakes outside ordersProfile →
Grupo Gollet Electronics
Guadalajara, Jalisco·101–250 employees·Job shop
- ✓ISO 13485
- ✓ISO 13485
- ✓ISO 9001
“ISO 13485:2016 – Medical Devices Quality Management System”
gollet.com.mxTakes outside ordersProfile →
Everwin-tutamen
Tijuana, Baja California·101–250 employees·Contract manufacturer
- ✓ISO 13485
- ✓FDA registered
- ✓IATF 16949
- ✓ISO 13485
“FDA-registered manufacturer, ISO 13485-certified, with ISO 7–8 cleanrooms for assembly”
tutamen.comTakes outside ordersProfile →
Andercraft de Mexico
Mexicali, Baja California·51–100 employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
“Our ISO 13485-certified manufacturing facility in Mexicali”
missionplastics.comTakes outside ordersProfile →
Fabrica de Equipos para Gases Medicinales
Tizayuca, Hidalgo·51–100 employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
- ✓ISO 9001
“Fabricante con Certificados en el Sistema de Calidad ISO 13485:2016 (Dispositivos Médicos) e ISO 9001:2015”
arigmed.comTakes outside ordersProfile →
Centerpiece
Playas de Rosarito, Baja California·51–100 employees·Contract manufacturer
- ✓ISO 13485
- ✓FDA registered
- ✓ISO 13485
“The company is FDA Registered and ISO 13485 Certified.”
centerpiece.lifeTakes outside ordersProfile →
HI Tech Products
Tijuana, Baja California·31–50 employees·Contract manufacturer
- ✓ISO 13485
- ✓ISO 13485
- ✓ISO 9001
“ISO 13485:2016 Certified”
hi-tech-products.comTakes outside ordersProfile →
Conamco
Cuauhtémoc, Ciudad de México·31–50 employees·Private label
- ✓ISO 13485
- ✓ISO 13485
“Our quality standards: ISO 13485”
medentalinternational.comTakes outside ordersProfile →
Hilados y Tejidos Quirurjicos
Juan C. Bonilla, Puebla·51–100 employees·Industrial supplier
- ✓ISO 13485
- ✓Cofepris
- ✓ISO 13485
- ✓ISO 9001
“ISO 13485:2016”
quirmex.com Profile →
Manufactura Dental Continental
Cuauhtémoc, Ciudad de México·11–30 employees·Industrial supplier
- ✓ISO 13485
- ✓ISO 13485
- ✓ISO 9001
“Contamos con certificaciones internacionales como ISO 9001:2015 e ISO 13485:2016”
dental.com.mx Profile →