Compliance Partners


ISO 11607:2006, part 1, outlines basic requirements for terminally sterilized medical device packaging. ISO 11607:2006, part 2, describes validation requirements for each step of packaging. Each contains extensive instructions that took more than five years to assemble and approve.

Karen Greene, technical director at DDL West (Costa Mesa, CA), encourages companies to contract out certain tasks. She recommends outsourcing for six key reasons: to reduce time to market, lower costs, create innovative design, effectively solve problems, comply with regulations, and extend sourcing networks such as rapid prototyping.

The area where Greene sees the most advantage is in reducing time to market. She says experienced contract packagers can act effectively as freelance engineers, and she has a checklist for potential outsourcing partners.

Among the key requirements for delivering medical device packaging systems to the clinical site or marketplace, in compliance with ISO 11607-1 and -2:2006 standards, Greene lists packaging system hazard analysis, labeling requirements, and evaluation of similar or competing devices.

“Hire outsourced professionals with the expectation of a virtual package engineer—meaning that they must own their role in bringing your medical device to the patient,” Greene says. Other qualities that she lists as essential to outsourcing partners include handling and understanding the clinical application of the medical device and proto­typing the packaging system.

The cost savings and design innovations Greene mentions arise from outsourcing. Assigning a contract firm to utilize their expertise in developing compliant packaging means that valuable time and money won’t be spent on training a company’s staff. Additionally, such experienced contractors will bring a fresh design approach to a package, thereby giving it an edge on the competition.

Placing responsibility on outsourcing services does not cede control and knowledge of intellectual property, Greene maintains. Instead, she views it as an astute business decision.

“Outsourcing package engineering lets a product design team leverage its own internal resources to more effectively deploy the available tools in the marketplace for package design, development, and qualification for compliance to reg­ulatory standards,” Greene says.


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