IFUcare (Qarad / QbD Group)
IFUcare, part of QbD Group, offers a full-service eIFU SaaS platform for IVD and MD manufacturers. They provide regulatory expertise, implementation support, and a multilingual call center to ensure compliance and efficiency.
IFUcare, a service of QbD IVD | Qarad, specializes in providing a comprehensive eIFU (electronic Instructions for Use) solution for medical device (MD) and in vitro diagnostic (IVD) manufacturers. As pioneers in this field, they help companies transition from paper IFUs to online accessibility, reducing risk and saving time and money in a compliant manner. Their validated SaaS platform is backed by regulatory experts and a full-service compliance team, ensuring adherence to EU/FDA regulations. IFUcare offers implementation support, handles regulatory changes, and perfects the validation process to meet Notified Body expectations. They are ISO 13485 and ISO 27001 certified. To address regulatory requirements for providing paper copies upon request, IFUcare includes a worldwide call center available 24/7. They are part of the QbD Group, a multinational organization with over 650 employees offering a wide range of services across the entire product lifecycle for life science companies.
About
**Who they are**
IFUcare (Qarad / QbD Group) is a full-service eIFU SaaS platform provider for IVD and MD manufacturers.
**Expertise & scope**
* Offers a Software-as-a-Service (SaaS) platform for electronic Instructions for Use (eIFU).
* Specializes in supporting In Vitro Diagnostic (IVD) and Medical Device (MD) manufacturers.
* Provides regulatory expertise to ensure compliance.
* Offers implementation support for seamless integration.
* Includes a multilingual call center for user assistance.
**Reputation / proof points**
* Part of the QbD Group, indicating a broader network of expertise.
IFUcare (Qarad / QbD Group) is a full-service eIFU SaaS platform provider for IVD and MD manufacturers.
**Expertise & scope**
* Offers a Software-as-a-Service (SaaS) platform for electronic Instructions for Use (eIFU).
* Specializes in supporting In Vitro Diagnostic (IVD) and Medical Device (MD) manufacturers.
* Provides regulatory expertise to ensure compliance.
* Offers implementation support for seamless integration.
* Includes a multilingual call center for user assistance.
**Reputation / proof points**
* Part of the QbD Group, indicating a broader network of expertise.
Additional information
IFUcare's eIFU platform is designed to streamline compliance and efficiency for medical device and IVD manufacturers. The service includes not only the SaaS platform but also crucial regulatory guidance and implementation assistance. Their multilingual call center is a key component for supporting end-users globally, ensuring that instructions are accessible and understood across different regions. This integrated approach aims to reduce the burden of regulatory compliance and enhance the user experience for medical products.
Key Highlights
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Offers a full-service eIFU SaaS platform for IVD and MD manufacturers.
Source
“IFUcare offers a full-service eIFU SaaS platform for IVD and MD manufacturers.”
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Provides regulatory expertise and implementation support.
Source
“They provide regulatory expertise, implementation support...”
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Includes a multilingual call center for compliance and efficiency.
Source
“...and a multilingual call center to ensure compliance and efficiency.”
Certifications & Trust Signals
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IFUcare is part of the QbD Group.
Source
“IFUcare, part of QbD Group, offers a full-service eIFU SaaS platform...”
Buyer Snapshot
Best for
- IVD manufacturers seeking eIFU solutions
- Medical device companies needing regulatory compliance support
- Organizations looking for a SaaS platform with implementation and support
How engagement typically works
- SaaS platform subscription
- Implementation support services
- Ongoing regulatory guidance
Typical deliverables
- Compliant eIFU platform access
- Regulatory expertise and consultation
- Multilingual customer support
Good to know
- Best when integrated into a broader compliance strategy for medical devices and IVDs.
HQ:
Antwerpen, Belgium
Languages:
English
Claim status:
Listed
Services & Capabilities
eIFU & Implant Card Platform
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Hosting Model:
SaaS
Paper On Request Fulfillment:
Included
Multilingual Support:
Yes
Validation Pack:
Yes
Compliance Certifications:
ISO 13485, ISO 27001
Additional eifu_platform Details
Hosting Details
Information not publicly available.
Compliance Certifications
MDR/IVDR compliance
