Qarad
★★★★★
4.7
/ 5
•
12 reviews
Qarad is a specialized consulting company with over 30 years of experience in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry. They are ISO 13485:2016 and ISO 27001:2022 certified.
Qarad is a leading consulting firm with over three decades of expertise in the In Vitro Diagnostics (IVD) and Medical Device (MD) sectors. They specialize in providing comprehensive solutions for Regulatory Affairs and Quality Systems, ensuring compliance and market access for their clients. As an ISO 13485:2016 certified company, Qarad focuses on quality management systems essential for medical devices. They also hold ISO 27001:2022 certification, demonstrating a commitment to high standards in Information Security. Their services extend to e-labeling (eIFU) solutions, offering a single-supplier approach developed by regulatory experts. Qarad is a proud member of the QbD Group, a multinational organization with over 600 employees. This affiliation allows Qarad to offer a broader range of services, including clinical affairs, qualification & validation, quality assurance, lab services, software solutions, and vigilance, supporting life science companies throughout the entire product lifecycle. The company boasts a team of highly qualified consultants with in-depth knowledge of IVDs and related regulations, including expertise in areas like immunoassays, next-generation sequencing, and PCR tests. They also collaborate with a network of selected professionals to ensure high-quality service delivery.
About
**Who they are**
Qarad is a specialized consulting company with over 30 years of experience in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry. They are part of the QbD Group.
**Expertise & scope**
* Regulatory Affairs and Quality Systems for IVD and Medical Device industry
* eIFU services for manufacturers to distribute technical documentation via a digital platform
* Consulting, training, authorized representative, performance evaluation, and e-labeling services for the medical devices industry
* Expertise in immunoassays, next generation sequencing, PCR tests, flow cytometry, and more
**Reputation / proof points**
* ISO 13485:2016 certified
* ISO 27001:2022 certified
* Experienced in the IVD and MD field since 1986
Qarad is a specialized consulting company with over 30 years of experience in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry. They are part of the QbD Group.
**Expertise & scope**
* Regulatory Affairs and Quality Systems for IVD and Medical Device industry
* eIFU services for manufacturers to distribute technical documentation via a digital platform
* Consulting, training, authorized representative, performance evaluation, and e-labeling services for the medical devices industry
* Expertise in immunoassays, next generation sequencing, PCR tests, flow cytometry, and more
**Reputation / proof points**
* ISO 13485:2016 certified
* ISO 27001:2022 certified
* Experienced in the IVD and MD field since 1986
Additional information
Qarad offers a comprehensive suite of services for the medical device and IVD industries, including acting as an authorized representative. Their expertise extends to technical documentation, post-market surveillance, and performance study documentation. They also provide eIFU (electronic Instructions for Use) services, helping manufacturers distribute technical documentation through a digital platform, with a focus on compliance and risk management. Qarad's team possesses in-depth knowledge of IVD regulations and a wide range of technical areas, ensuring high-quality services for protecting regulatory interests.
Key Highlights
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Over 30 years of experience in Regulatory Affairs and Quality Systems for the IVD and Medical Device industry.
Source
“More than 30 years experience in IVD”
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ISO 13485:2016 certified for quality management systems in the medical device industry.
Source
“Qarad is an ISO 13485:2016 certified company.”
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ISO 27001:2022 certified, demonstrating commitment to information security management.
Source
“ISO 27001 certified”
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Offers specialized eIFU services for digital distribution of technical documentation.
Source
“also resulted in the development of our eIFU services.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- IVD and Medical Device manufacturers seeking regulatory and quality system support
- Companies needing an EU Authorized Representative
How engagement typically works
- Consulting and training services
- Provision of specialized services like eIFU
Typical deliverables
- Technical documentation support
- Post-market surveillance plans
- Performance study documentation
- eIFU solutions
- Authorized Representative services
Good to know
- Best when requiring specialized regulatory and quality system expertise for IVDs and medical devices.
HQ:
Antwerpen, Belgium
Languages:
English, French, Dutch
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
BE, NL, FR, DE
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 3,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports IVDR:
Yes
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Belgium
Vigilance Contact Support:
Yes
Device Classes Supported:
IVD
Additional eu_ar Details
Supports MDR
true
Supports IVDR
true
EU Entity Country
Belgium
Fsca Recall Support
true
Post Market Support
true
Vigilance Contact Support
true
Onboarding Steps
The provided content does not detail specific onboarding steps, required documents, timelines, or setup processes.
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
