About
IFUcare enables medical device (MD) and in vitro diagnostic (IVD) manufacturers to leave paper instructions for use (IFU) out of product packaging and make them accessible online. IFUcare (part of the QbD Group) is a service powered by a team of regulatory experts specialized in MDs and IVDs. As a pioneer in offering electronic IFU (eIFU) services, we have successfully tackled many of the challenges in implementation such as dealing with changes in regulations and perfecting the validation process to fulfill Notified Body expectations. We are ISO 13485 and ISO 27001 certified.
Technologies
Amazon SES
Outlook
Microsoft Office 365
Zendesk
Hubspot
Google Tag Manager
Google Maps (Non Paid Users)
Nginx
Linkedin Marketing Solutions
Google Font API
Google Maps
Mobile Friendly
WordPress.org
Vimeo
Keywords
medical equipment manufacturing
regulatory affairs
cloud-based software
document management
consulting
services
eifu for global markets
eifu for healthcare providers
eifu for implantable devices
product lifecycle management
validated website
eifu validation process
eifu platform
healthcare equipment & supplies manufacturing
regulatory guidelines
eifu regulation us
iso 27001
iso 13485
restricted access
medical equipment and supplies manufacturing
online distribution platform
fda regulation
regulatory consulting
b2b
eifu subscription module
eifu for ivds
regulatory updates
cost savings
medical devices
change management
Company Information
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Employees 3
Location
257 Pas, Roeselare, Vlaams Gewest, Belgium, 2440