With over 80 years of combined contract services experience the I-Tek team has collectively designed, developed and commercialized over 150 medical devices. From Class I to Class III devices, we understand the technical challenges of research and development along with the regulatory hurdles required to release products to commercialization.
I-Tek offers a full range of medical device services from early conception/prototyping through development and onto verification and validation testing including packaging and sterilization validation with project management throughout the entire process. We operate in an FDA GMP compliant facility with ISO 13485 certification. I-Tek employees are experts in medical device development and commercialization processes allowing our customers to receive the highest quality service in a rapid and cost effective manner.