Advanced Concept Innovations

Lakeland FL. — Advanced Concept Innovations LLC. (ACI), offers medical device marketers complete project management for contract manufacturing and packaging - Including development, package design, prototyping, validation, regulatory, and sterilization guidance. In a highly regulatory environment, ACI can consult on 510 filing and CE Mark registration as part of a project management package.

Serving the global marketplace, ACI is ISO 13485 certified and compliant with FDA, GMP and QSR 21 Part 820. Providing complete solutions for designing your medical device packaging using form, fill and seal technologies such as thermoforming and sealing operations in rigid and flexible materials along with pouch manufacturing. ACI performs operations in GMP and cleanroom environments.

ACI offers consultation for material selection, biocompatibility, and aging/self life and sterilization validation along with full process validations for medical device manufacturing compliance.