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
IFUcare (Qarad / QbD Group) is a specialized eIFU SaaS platform provider for IVD and MD manufacturers, offering regulatory expertise and implementation support. They focus on enabling manufacturers to transition from paper-based Instructions for Use (IFU) to accessible online formats, thereby enhancing compliance and efficiency. The platform is designed to address the complexities of regulatory changes and validation processes required by Notified Bodies. IFUcare is part of the QbD Group and emphasizes a secure, validated, and compliant solution tailored for the life sciences industry. Their services aim to help companies navigate the evolving regulatory landscape, including the implications of MDR and IVDR, by ensuring their eIFU websites meet stringent compliance requirements.
Additional information
IFUcare's eIFU platform is designed to ensure regulatory compliance, as a manufacturer's website becomes an extension of their medical device once the eIFU is live, subject to MDR and IVDR requirements. They emphasize the importance of eIFU validation for meeting stringent industry standards. The company also highlights the shift towards digital IFUs, citing industry publications and regulatory updates that encourage wider adoption, particularly for near-patient tests and professional-use devices. IFUcare provides resources such as blog posts and readiness tests to help manufacturers navigate this transition and assess their device eligibility for eIFUs.
Key Highlights
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ISO 13485 and ISO 27001 certified.
Source
“We are ISO 13485 and ISO 27001 certified.”
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Pioneer in offering electronic IFU (eIFU) services.
Source
“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.”
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Offers a full-service eIFU SaaS platform.
Source
“IFUcare, part of QbD Group, offers a full-service eIFU SaaS platform for IVD and MD manufacturers.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- IVD and Medical Device manufacturers seeking eIFU solutions
- Companies needing regulatory expertise for digital IFUs
- Organizations aiming to comply with MDR and IVDR for IFUs
How engagement typically works
- SaaS platform provision
- Implementation support
- Regulatory guidance
Typical deliverables
- Compliant eIFU platform
- Validation support
- Multilingual customer support
Good to know
- Best when transitioning from paper IFUs to digital formats
- Best when requiring adherence to strict medical device regulations
HQ:
Antwerpen, Belgium
Languages:
English
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
ISO 13485, ISO 27001, MDR, IVDR compliance support
