In the free, on-demand webcast “Speed Up Your Compliance Process—With Help from DuPont Tyvek,” experts from leading packaging materials manufacturer DuPont outline the packaging implications of six global regulatory changes for medical device manufacturers:
• European Union Adopted its MDR/IVDR in April 2017 to replace the MDD/IVDD;
• Association of Southeast Asian Nations (ASEAN) Medical Device Directive 2015;
• India “Medical Device Rules, 2017” notified in January 2017;
• Eurasian Economic Union (EAEU) 2016 Legal framework for medical products;
• International Medical Device Regulators Forum (IMDRF) Guidance and harmonization;
• ISO TC210 published ISO 13485:2016, a significant revision of QMS requirements.
Because of these upcoming regulatory changes, medical device manufacturers will need to update their technical files; recognize that changes may have an impact on existing validations and packaging designs; and adapt labeling.
Doing so will ensure the development of packages that help end-users ensure the safe use of sterile medical devices.
The DuPont speakers also share tools to help you with packaging design and regulatory submissions.
Click the headline link above to read the full article. Click the webcast title link to go directly to the registration page for access to the free webcast.
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