Regulatory agencies’ concern for labeling and packaging of a medical device leads to product quality scrutiny. Medical device package validations are a key component for all medical device design history files and regulatory submissions. Whether the device is sterile or nonsterile, the packaging of the product, to ensure it arrives as intended, is of the utmost importance.
WuXi AppTec’s technical experts approach these validations looking at the components of the packaging individually and as a whole. Our validation design will verify package integrity, seal strength and burst properties evaluation, and distribution of the final finished devices – whether the pallets, boxes, or cartons delivered remain intact.
Our validation services include:
- Seal Peel Strength
- Burst/Creep Strength
- Bubble Emission Test
- Vacuum Leak
- Dye Immersion / Dye Penetration
- Accelerated Aging / Shelf Life Studies
- Simulated Distribution
Package design is a critical step of the device development phase. We want to work with you to confirm your packaging will safely deliver your product to the end user. The validation design considers your product and its unique characteristics.
In addition, our testing services expand beyond package validations. We offer regulatory and technical recommendations that provide you with a more comprehensive test plan to meet the ever-evolving regulatory environment.
To speak with our technical and regulatory experts, contact us today to arrange a meeting.
Email firstname.lastname@example.org or call 651-675-2000.