I 3 CONSULTING

I 3 CONSULTING, We are leading Global Quality Assurance & Regulatory Consultants & In-Country Representatives (EU & FDA) to healthcare industries to comply with European and US FDA requirements.

Provide complete regulatory certifications and advise to worldwide medical device companies as well as healthcare sectors.

Our network of 100+ management and pharma consultants, 10+ testing laboratories, 36+ full-time technical consultants, 4+ office locations in different countries and well-wishers from 3600 + satisfied customers makes us one of the most reputed and trusted service provider delivering economic, quality, time-bound, solutions to the customers across the globe.

1) CE
2) ISO9001:2008
3) ISO 13485:2003
4) WHO-GMP Compliant
5) US FDA 510(K)

2005

clinical evaluation, clinical evaluation plan template, literature search protocol, CER writing, medical device consulting, US FDA consulting, CE marking, FDA registration, Regulatory Consulting, Quality Assurance, post-market surveillance, post-market clinical follow-up, Medical Device CE Marking, 510k submission, Software CE Marking, Technical File, EU representative, Biocompatibility testing, Class 1 medical device, Medical Device Classification, FDA Medical Device Registration