IFUcare published a blog explaining what to check now to get eIFU setup EUDAMED-ready.
Published
Signal category
Research & Knowledge
Quote
“In our latest blog, we explain what to check now to get your eIFU setup EUDAMED-ready.”
— IFUcare team
Company
IFUcare
E-labeling created by regulatory experts in MD & IVD | part of the QbD Group
- Industry
- Medical Equipment Manufacturing
- Location
- Geel, BE
- Company size
- 3 employees
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.