Lourdes Cantero

I.C.S Integrity Consulting Services

Integrity Consulting Services has more than 27 years of experience in the Medical Devices Industry. We have been assisting Medical Device and IVD companies with Regulatory Affairs, Quality Systems and Clinical Investigations issues since 1994. Whether you wish to enter the USA (FDA) and /or EU markets (CE), or to introduce another new medical device, we can assist with everything from 510K / CE-Mark , QSR / ISO 13485:2003 Quality System compliance and audits, to Clinical investigations Investigator Brochure and sub contracture qualification. Integrity Consulting Services can help you to obtain regulatory clearance, maintain compliance and increase your sales in the world's largest and fastest growing Medical Device and IVD markets. Our Services are covering all your needs Regulatory, Quality Assurance and Clinical Investigations, all of them under the same roof. We have professional team that has a proven records for successfully entering dozens of Medical Devices and IVD to following markets: >USA (FDA Medical Devices and IVD) >EU (MDD and IVD) >Israel (MOH AMAR Medical Devices and IVD) >Japan (PAL) >Canada (MDL) >Korea (KFDA) >China (SFDA) >Brazil ( Anvisa)