To address the stringent quality systems requirements of our customers we became an ISO 9001 certified company in 1998. In addition to our ISO certification, we have an International Safe Transit Association (ISTA) certified testing laboratory.

The lab has undergone a significant capital equipment upgrade to provide additional testing capabilities required to first evaluate our initial designs then fully validate the Sterile Barrier Packaging Systems.

PackagingMD’s focus will be to provide value-add consulting services that enable the reduction of the cycle time for new medical technologies by following the FDA’s design control requirements throughout the design, development and validation phases. Working closely with the medical technology company we will:

• Establish Package Design Inputs
• Complete a Risk Analysis
• Determine Sample Size
• Identify Acceptance Criteria
• Develop Protocols
• Finalize Completion Reports
• Participate in Design Reviews

We welcome the opportunity to answer any questions that you may have and invite you to schedule a detailed audit of our quality systems. Please contact our quality manager at Quality@PackagingMD.com