Geel, Belgium, 20 October 2022 – Qarad, a leading consulting company, focusing on Regulatory Affairs and Quality Systems for the IVD and Medical Device industry, today announced the rebranding of its existing eIFU (electronic Instructions For Use) services, into the new and independent IFUcare brand.
IFUcare is a full-service solution for the distribution of Electronic Instructions for Use (eIFU) of Medical Devices and IVD products. It consists of a pre-validated hosting platform and the support of IFUcare’s regulatory expert team. Therefore, it allows medical device and IVD manufacturers to distribute their instructions for use and other regulatory documents in a compliant way. It not only adds simplicity and cost-efficiency to the process but also makes the end result more client-friendly and compliant with regulations.
The rebranding follows the integration of Qarad into the QbD Group (Wilrijk, Belgium) in early September 2021, and will position IFUcare as a premium service in the IVD and Medical Device industry for both existing clients and new prospects alike.
Dirk Stynen, Ph.D., Founder and GM of Qarad comments
“For some fifteen years now, our eIFU services have stood out as a true innovation in compliant distribution of online instructions and regulatory documents for medical and IVD devices. And in close consultation with our new strategic and fast-growing partner the QbD Group, we chose to rebrand and upscale it into the stand-alone IFUcare brand, making it more visible to the outside world, and enabling it to more explicitly position itself as a leading platform in this field.”
“For existing clients nothing will change, except the look and feel of the brand. Its services and performance will remain on the same supreme high level as before, just like client account management and contacts.”
“The QbD Group on the other hand, with the expansion of this service offering and IVD expertise, is boosting its international reputation as the number one partner for clients that need guidance in the full ‘from idea to patient’ life cycle of their Medical Device.”
IFUcare: an ISO 13485 & ISO 27001 eIFU solution by Qarad
eIFU stands for “electronic instructions for use”, but the term encompasses more than just these documents. It also includes the online distribution of other regulatory documents, such as certificates of analysis, safety data sheets, and quality control documents.
eIFU can be made available via a manufacturer’s website but due to the strict regulations, these websites must be validated for compliance. IFUcare removes this burden and offers a pre-validated website, still matching the corporate identity of the manufacturer. Moreover, maintenance and continued compliance are ensured.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.