Experts Analyze Medical Device Packaging Market
Karen Greene
Healthcare Packaging
Article Summary
Karen Greene, CPP, technical director, DDL Inc., a provider of testing services, package design, prototyping, and consulting, noted that compliance with Intl. Standards Organization standard 11607 “is a must in this FDA-regulated industry.” The 11607 standard is a harmonized, globally accepted industry standard for terminally sterilized medical devices. TIR (Technical Information Report) 22 is a guidance document to comply with ISO 11607, she explained. Greene recommended that device makers see if their company’s data can be leveraged and used in compliance. “A thorough package compliance program is a competitive advantage for your company,” she said.
