The information in instructions for use (IFU) for medical devices and in vitro diagnostics (IVD) is both highly regulated and fundamental to patient safety. For manufacturers of medical devices and IVDs, it is essential to know they can rely on their service providers. Thanks to Qarad’s deep expertise in IVDs and medical devices and its long experience in regulatory affairs, its service stands out from the rest.
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 of medical devices and IVDs, it is essential to know they can rely on their service providers.
The right customer support and communication is the hallmark of a valuable partner and crucial to an effective, efficient and lasting working relationship.
Thermo Fisher Scientific is a leading international supplier of life sciences products, offering a suite of IVDs. Historically, they relied on manual processes to produce paper IFU which had to be printed, folded and inserted into device packaging. Ten years ago, as part of Thermo Fisher’s Practical Process Improvement (PPI) protocol, the company transitioned to electronic instructions for use (eIFU) and chose eIFU expert Qarad to host its platform. The relationship between Thermo Fisher and Qarad is built on a mutual commitment to excellence and a foundation of trust.
Päivi Väänänen was part of the PPI team ten years ago and has remained a point of contact with Qarad ever since. Now marketing communications manager for Thermo Fisher Scientific Analyzers & Automation and Clinical Mass Spectrometry Business Units, Väänänen explains that the value of the relationship comes from Qarad’s unique expertise and experience. “I know that Qarad has the regulatory expertise, and that makes me very confident,” she says. “We can be confident that Qarad is following the latest regulations, and we can rely on their services.”
Uniquely qualifying Qarad to provide robust, high-quality services to IVD and medical device manufacturers is the expert regulatory consulting service which lies at the core of its business. The eIFU platform itself is rigorously validated through an in-depth assessment process, meaning that clients like Thermo Fisher can rely on its regulatory compliance.
For Thermo Fisher, one of the most valuable features of the Qarad service is its ability to meet the regulatory requirement of offering a 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. “Qarad provides 24/7 phone support, which is very valuable to us.” Alongside this, Qarad meets the requirement of providing paper IFU copies on demand.
In the spirit of constant improvement, and out of a commitment to meeting its customers’ needs, Qarad has recently introduced the newest version of its eIFU platform. This platform is based on a decade of eIFU experience and offered directly to Qarad customers.
For Thermo Fisher Scientific, the new platform 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. “And we can now have different versions of the same instructions visible on the platform. We might have the situation where we need both IVDD and IVDR related instructions at the same time, and that’s possible.”
Not only have the regulatory capabilities been enhanced, but the new platform is also designed for greater business and operational efficiency.
“We have also been able to combine our different business units from within Thermo Fisher Scientific,” says Väänänen. “Now, we have one agreement and one site, with our own sections on the site. That way, it is more cost effective.”
The process of migration to the new platform could have been a daunting one, with the needs of Thermo Fisher customers all over the world to keep in mind, but Qarad facilitated a process that was straightforward, effective, and went off without a hitch.
“We have over 10,000 documents on the site, so we really had to make sure that nothing would happen to affect our customers. We also changed our email address in this process, in connection with IVDR compliance project,” says Väänänen. “Qarad was very helpful. They put routing in place so people are redirected to the new platform. The process went smoothly, and there was no harm caused to our clients.”
Qarad customers do not simply receive services, but enter into a partnership – and, as in any partnership, communication is key. It starts with onboarding. Qarad offers virtual or in-person training sessions alongside paper resources, including instruction manuals. This training is in-depth and step-by-step, drawing on case studies and written materials. At this stage, too, customers have the opportunity to configure the platform to their company’s needs.
“With the first version of the platform, we got very good instructions and virtual training,” says Väänänen. “And during the migration process, we had access to a sandbox where we could practice with the new site, and that was really helpful. The process worked very well.”
The relationship doesn’t end there. Qarad’s support team offers ongoing guidance, answers questions and solves issues. Throughout Qarad’s ten-year partnership with Thermo Fisher, Väänänen has enjoyed direct communication access to Qarad experts – though she notes, there has never been an urgent case for its use. “Over ten years, we have seen how reliable the platform is,” she explains. “There have only been very rare cases where we have had to contact Qarad – but when we do, the answer comes back very quickly.”
Thanks to Qarad’s deep expertise in IVDs and medical devices and its long experience in regulatory affairs, its service stands out from the rest. Its many specialist consultants have a unique wealth of knowledge about EU and FDA regulations, putting them in an ideal position to understand its customers’ needs.
“They are capable of putting themselves into the customer’s shoes,” explains Väänänen. “They understand our questions. In this kind of environment, you can sometimes have difficulties with communication, but in Qarad’s case, if I don’t understand something, it’s very easy to ask and get clarification.”