Boulder iQ is an expert contract design and development firm offering design and development engineering for consumer, industrial and medical device products, and complete services for regulatory and quality management systems for the medical device industry. In its design engineering work, Boulder iQ specializes in innovation, human factors, and technology system design from concept through manufacturing. Services for the medical device and IVD industries include guidance on global medical device clinical regulations (ISO 13485:2016 certification through Boulder BioMed). Additional services include regulatory consulting for U.S. FDA classification, submissions for EU MDR technical file documentation, and clinical evaluation reports.