AVAILABLE NOW:
New Webinar & White Paper Focused on Medical Device Package Testing to Comply with the MDR

The Importance of Thorough Package Performance Evaluation to Support Compliance with the New Medical Device Regulations (MDR)

Tyvek® Medical & Pharmaceutical Protection is proud to release the latest white paper and webinar to the general public. PDFs and video replay are available for immediate access upon completion of the registration form to the right.

Webinar Topics

The EU MDR takes effect in May 2020, and with these regulatory changes come new key requirements for sterile packaging validation. The MDR states:

"Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer."

Join Tyvek® team members Nicole Kaller and Laetitia Clerc as they share DuPont's experience applying test protocols that can be applied to help validate medical packaging in accordance to MDR. Through this webinar (aired June 6, 2019) and white paper, our technical research experts discusses the newly published results of the second phase of our Medical Device Package Testing Case Study. Read part 1 of this research study (October 2018) here

In this webinar we discuss the new white paper which addresses the most important steps of a thorough package performance evaluation:

  • Comparison of four different types of porous packaging materials: Tyvek® 40L, Tyvek® 2FS™, Reinforced Medical-Grade Paper >80g, Direct Seal Medical-Grade Paper 60g in terms of packaging performance
  • Testing according to recognized test standards
  • Based on a statistical sample size definition method
  • Reporting and analysis of package strength and integrity testing results pre-sterilization, post-sterilization (EO, gamma), post standard environmental conditioning/pallet and wet conditioning/shipper transportation testing

Who Should Watch This Webinar & Read the White Paper?

  • Packaging Engineers
  • Validation Engineers
  • Production Engineers
  • Regulatory Affairs
  • Quality Assurance
  • Project Managers
  • Technical Management
  • Sterilization Engineers
  • Research & Development (R&D)
  • Laboratory Technicians

Speakers

Nicole KallerNicole Kaller
Application Development Leader EMEA
DuPont™ Tyvek® Medical & Pharmaceutical Protection

Laetitia ClercLaetitia Clerc
Global Technology Market Leader
DuPont™ Tyvek® Medical & Pharmaceutical Protection

Register for Immediate Access to
New Webinar & White Paper

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