Training & Education in Colorado

Boulder iQ is a specialized life sciences consulting and contract services firm headquartered in Boulder, Colorado, providing comprehensive support to medical device, diagnostic, and combination product companies. The firm operates as a family of integrated companies: Boulder iQ (engineering, design, development, and manufacturing); Boulder Sterilization (contract sterilization services); Boulder Regulatory Affairs and Quality Assurance (regulatory and QA support); and Boulder BioLabs (contract testing and validation). With over 40 years of collective expertise and ISO 13485:2016 certification, Boulder iQ serves clients across 33 U.S. states and 6 countries. The company specializes in concept-to-commercialization support, including product design, prototyping, manufacturing, quality systems, regulatory pathway navigation, and sterilization validation. Boulder Sterilization is recognized as the sole U.S. contractor offering both ethylene oxide and chlorine dioxide sterilization, and the world's largest contract chlorine dioxide sterilizer.

Prospect Life Sciences is a medical device development and contract manufacturing partner headquartered in Westminster, Colorado. The company provides integrated end-to-end services spanning research & design (R&D), product development (NPI), manufacturing transfer, and full-scale production. Core capabilities include concept validation, prototyping, design history file (DHF) creation, verification and validation (V&V) testing, process validation (IQ/OQ/PQ), supply chain establishment, and scalable manufacturing with facilities in both the USA and Costa Rica. The company is ISO 13485:2016 certified and FDA registered, operating under 21 CFR 820 quality system regulations. Prospect serves early-stage innovators, academic spin-outs, and established medical device companies across multiple therapeutic areas, including GI endoscopy, spinal implants, surgical instruments, diagnostic kitting, wheelchair mobility devices, dental instruments, and electro-medical devices. The firm bridges the "Valley of Death" between product development and commercial manufacturing, providing hands-on project management, regulatory guidance for FDA clearance and CE marking, and quality system implementation support. Manufacturing capabilities include precision assembly, kitting, fulfillment, and sterile processing (including 503B pharmaceutical outsourcing). The company emphasizes flexibility, responsiveness, and risk mitigation throughout the product lifecycle.