Validation & Testing Requirements for Medical Device Packaging

Pavankumar Tailor, senior research associate for packaging and mechanical testing in the Healthcare and Medical Devices division of TÜV SÜD South Asia, begins his presentation by defining medical device packaging and classifying packaging types and sealing methods. He poses, and anwsers, the question: "Why is packaging important?" — then shares data on reported medical device recalls due to packaging failures over the last two years.

Next, the webinar segues into the importance of packaging validation to ensure product quality and prevent packaging failures: Tailor shares that ISO 11607-1 & 2 are general standards for medical device package testing and validation guidance that will help attendees choose a perfect packaging system and validate it.

The webinar covers the stages of validation, package testing requirements, and different types of packaging tests. Tailor also discusses different countries' regulatory bodies and their guidelines for testing requirements.