Advanced Package Design and Validation

Expertly designed and well-executed packaging is an incredibly important, but often overlooked, aspect of the post-manufacturing process. Millstone Medical Outsourcing offers medical device manufacturers industry-leading packaging design and validation services. Our services make it possible for customers to bring products to market efficiently and cost-effectively while maintaining quality and ensuring regulatory compliance.

With packaging design and validation as a core competency, Millstone serves as a key resource to our customers’ internal teams throughout a product’s life cycle. Our services are closely aligned with the industry’s most comprehensive regulatory standard: ISO-11607, “Packaging for Terminally Sterilized Medical Devices,” and provide customers with documentary evidence of compliance. Service offerings include:

• package design from material selection through primary, secondary, and tertiary package design
• package development from risk analysis to design control
• process and package design validation from equipment selection through final package design verification