Irwin & Associates

Irwin & Associates is a leading medical device consultancy based in California. The firm has over 22 years of experience supporting companies in the medical device and biotechnology sectors. Their expertise spans quality engineering, regulatory strategy, project management, design control, technical writing, R&D, software compliance, clinical education, manufacturing engineering, sterilization/biocompatibility assessments, verification/validation processes, process development support, internal auditing—essentially covering all phases of product lifecycle from concept to commercialization[1][2]. They are recognized for their deep industry knowledge and strong client relationships with top Bay Area medtech firms.