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 established in 2008, specializing in solutions for IVD and MD manufacturers.
**Expertise & scope**
* Offers a pre-validated website for online distribution of electronic Instructions for Use (eIFU).
* eIFU encompasses more than just instructions, including certificates of analysis, safety data sheets, and quality control documents.
* Provides regulatory expertise and implementation support.
* Ensures continued compliance and maintenance of the eIFU platform.
* Offers a multilingual call center to support users.
**Reputation / proof points**
* ISO 13485 Certified
* ISO 27001 Certified
* Part of QbD Group
IFUcare (Qarad / QbD Group) is a full-service eIFU SaaS platform provider established in 2008, specializing in solutions for IVD and MD manufacturers.
**Expertise & scope**
* Offers a pre-validated website for online distribution of electronic Instructions for Use (eIFU).
* eIFU encompasses more than just instructions, including certificates of analysis, safety data sheets, and quality control documents.
* Provides regulatory expertise and implementation support.
* Ensures continued compliance and maintenance of the eIFU platform.
* Offers a multilingual call center to support users.
**Reputation / proof points**
* ISO 13485 Certified
* ISO 27001 Certified
* Part of QbD Group
Additional information
IFUcare's eIFU platform goes beyond simple document hosting by offering a pre-validated website solution. This approach removes the regulatory burden from manufacturers, as the website is designed to meet strict compliance requirements. The service ensures that electronic Instructions for Use, along with other critical regulatory documents like certificates of analysis and safety data sheets, are accessible and maintained. Their offering includes ongoing maintenance and compliance assurance, simplifying the process for manufacturers and improving the readability and accessibility of essential information for end-users.
Key Highlights
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Offers a full-service eIFU SaaS platform for IVD and MD manufacturers.
Source
“IFUcare, part of QbD Group, offers a full-service eIFU SaaS platform for IVD and MD manufacturers.”
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Provides a pre-validated website for online distribution of eIFU and other regulatory documents.
Source
“Distribute your documents online on a pre-validated website”
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Ensures continued compliance and maintenance of the eIFU platform.
Source
“Moreover, maintenance and continued compliance are ensured.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- IVD manufacturers seeking eIFU solutions
- MD manufacturers requiring regulatory document distribution
How engagement typically works
- SaaS platform implementation
- Regulatory expertise support
Typical deliverables
- Pre-validated eIFU website
- Regulatory document hosting and distribution
- Multilingual call center support
Good to know
- Best when a dedicated, compliant eIFU platform is required.
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
Offers a pre-validated website for eIFU hosting.
Compliance Certifications
ISO 13485 Certified, ISO 27001 Certified
