PSN Labs has successfully expanded its ISO 13485 certification to include design and development. This adds to the company’s existing certification for injection molding of medical device components.

The Erie, Pa.-based company has long offered integrated design and development services, but this certification formally recognizes rigorous processes already in place. It also allows PSN Labs to play a larger part in helping navigate technical and regulatory challenges early on.

PSN Labs’ end-to-end engineering services rely on an integrated product development approach that’s designed to balance performance, safety, and regulatory compliance. The approach starts with designing for compliance to ensure regulatory readiness and incorporates design for manufacturability and assembly to create scalable, efficient solutions.

Design for commercialization then balances cost, performance, and scalability to support success in the market, the company said. Design for biocompatibility then ensures materials and processes are optimized early to streamline later regulatory submissions and de-risk technical and regulatory hurdles.

The company regularly conducts stage-gate reviews with clients and internal teams, keeping complete design history files to support traceability, quality, and compliance. Its multidisciplinary team consists of experts in mechanical, plastics, biomedical, and design engineering, alongside material scientists, chemists, biologists, toxicologists, and other specialized professionals.

Adding to engineering and molding services, PSN Labs also operates an ISO/IEC 17025-accredited testing lab, providing biocompatibility testing, drug stability assessments, and regulatory consulting.

“Our team is proud to continue to help clients de-risk their products by leveraging our unique integrated product development process to bring high-quality products and devices to market faster, safer, and with cost in mind,” said Mark Burchnall, P.E., PSN Labs’ director of engineering.