The information that appears in instructions for use (IFU) for medical devices and in vitro diagnostics (IVD) is both highly regulated and fundamental to patient safety. For manufacturers, it is essential to know they can rely on their service providers.
Confidence in compliance
Thermo Fisher Scientific transitioned to electronic instructions for use (eIFU) ten years ago and chose IFUcare to host its platform. Päivi Väänänen, marketing communications manager, explains: "I know that IFUcare has the regulatory expertise, and that makes me very confident. We can be confident that IFUcare is following the latest regulations."
One of the most valuable features is the free, multilingual phone support service. "We could use our own website to host eIFU, but it was clear that we couldn't fulfill the requirement for phone support," says Väänänen. "IFUcare provides 24/7 phone support, which is very valuable to us."
Another step forward
IFUcare's newest platform version offers brand new capabilities. "Our regulatory team is very happy that we can now offer customers instructions specific to the country they are in," explains Väänänen. "We have also been able to combine our different business units from within Thermo Fisher Scientific. Now, we have one agreement and one site."
"We have over 10,000 documents on the site, so we really had to make sure that nothing would happen to affect our customers. IFUcare was very helpful. The process went smoothly."
The IFUcare difference
Thanks to IFUcare's deep expertise and long experience in regulatory affairs, its service stands out. "They are capable of putting themselves into the customer's shoes," explains Väänänen. "Over ten years, we have seen how reliable the platform is."
