Packaging Compliance Labs
Packaging Compliance Labs provides ISO-compliant packaging solutions and testing services for medical devices, with facilities in Grand Rapids, MI and a sales office in Boulder, CO.
Services
Packaging Compliance Labs offers a variety of services including ISO 11607-compliant expedited packaging solutions through CompliancePack™, and ISO 17025-accredited package testing for medical devices. The company provides low- to mid-volume contract packaging services, transit testing, shelf-life testing, and sterile barrier package integrity testing. Additionally, they manage sterilization validation and sterile product management, and offer turnkey sealer validation and transit root cause analysis. Packaging Compliance Labs also supports clients with test method validation services and pre-validated packaging options such as single- and dual-barrier film-to-Tyvek pouches and trays.
Certifications and Accreditations
Packaging Compliance Labs is ISO 13485-2016 certified and FDA registered, demonstrating their commitment to quality standards and regulatory compliance in the medical device industry. The company's state-of-the-art packaging testing lab is ISO 17025-accredited, ensuring their testing processes meet industry standards for accuracy and reliability.
Testing Capabilities
Packaging Compliance Labs provides comprehensive testing capabilities specifically for medical devices. These include transit testing, shelf-life testing, and sterile barrier package integrity testing. Additionally, they offer rigorous validation services such as test method validation and turnkey sealer validation. Their ISO 17025-accredited lab ensures precision and adherence to industry standards.
Locations
Packaging Compliance Labs operates two laboratories in the greater Grand Rapids, MI area, providing local support and extensive testing capabilities to their clients. They also have a sales office located in Boulder, CO, enabling them to serve a broader geographical region and establish closer relationships with clients on the west coast.
Target Industries
Packaging Compliance Labs primarily focuses on the medical device packaging sector but also supports the pharmaceutical and diagnostics industries. By partnering with medical device manufacturers, development firms, and start-ups, the company provides specialized packaging solutions and services tailored to the unique requirements of these industries.