Maintaining approval for medical devices and sterile packaging during the transition
A significant modification in the technology used in the manufacture of Tyvek® material found in a wide variety of medical devices and sterile packaging will now require manufacturers of currently approved Tyvek®-based products to re-evaluate them for continued compliance with applicable standards and regulations. This white paper presents the details of the production transition regarding Tyvek®, and summarises the likely steps necessary to ensure the continued recognition of previously approved medical devices and packaging that incorporate Tyvek® material.
Why download this white paper?
- Understand medical device sterile packaging requirements and standards.
- Learn about Tyvek® and medical device packaging.
- Gain an overview of required actions for maintaining EU notified body certification.