Qarad
Verified
★★★★★
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 Devices
* eIFU services for manufacturers to distribute technical documentation via a digital platform
* Consulting, training, authorized representative, performance evaluation, and e-labeling services
* Expertise in immunoassays, next-generation sequencing, PCR tests, flow cytometry, and more
* Support for IVD Technical Documentation, Post-Market Surveillance, and Performance Study Documentation
**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 Devices
* eIFU services for manufacturers to distribute technical documentation via a digital platform
* Consulting, training, authorized representative, performance evaluation, and e-labeling services
* Expertise in immunoassays, next-generation sequencing, PCR tests, flow cytometry, and more
* Support for IVD Technical Documentation, Post-Market Surveillance, and Performance Study Documentation
**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 beyond traditional regulatory consulting, including specialized eIFU (electronic Instructions for Use) solutions. Their approach to eIFU focuses on providing a single-supplier solution developed by regulatory experts, emphasizing compliance and risk management for manufacturers. This integrated service helps streamline the distribution of technical documentation through a digital platform, making regulatory compliance more efficient for clients in the IVD and Medical Device sectors.
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 specialized regulatory and quality system support.
- Companies needing assistance with technical documentation, post-market surveillance, and performance studies.
- Businesses looking for eIFU solutions to manage technical documentation digitally.
How engagement typically works
- Consulting and training services.
- Provision of authorized representative services.
- Development and implementation of quality management systems.
Typical deliverables
- ISO 13485:2016 and ISO 27001:2022 compliant quality systems.
- Technical documentation and post-market surveillance support.
- eIFU platform implementation and management.
- Regulatory affairs consulting.
Good to know
- Best when clients require deep expertise in IVD and Medical Device regulations.
- Ideal for companies prioritizing compliance and risk management in their regulatory strategy.
HQ:
Antwerpen, Belgium
Website:
qarad.com
Public email:
ecrep@qbdgroup.com
Phone:
+32 (0)14 49 04 22
Languages:
English, French, Dutch
Timezones:
Europe/Brussels
Access:
Verified
Claim 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, Class I, Class IIa, Class IIb, Class III
Supports MDR:
Yes
Fsca Recall Support:
Yes
uk_rp
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
GBP 4,000
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
Supports NI:
Yes
MHRA Support:
Yes
ch_rep
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Vigilance Contact Support:
Yes
Labeling Support:
Yes
Swiss Local Contact:
Yes
Swiss Entity Canton Or Region:
Zug
Can Be Named On Label:
Yes
prrc_service
Jurisdictions:
EU
Countries:
BE
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
EUR 2,500
Included services:
Outsourced PRRC designation (MDR/IVDR Article 15), QMS and technical documentation review before PRRC role start, Responsibility for product compliance before notified bodies and competent authorities, Notification of audits, QMS/product changes, complaints, recalls, field safety, Permanent availability; structured designation process with intensive involvement
Named PRRC:
Yes
Availability Hours:
Business hours
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
Qarad offers outsourced Person Responsible for Regulatory Compliance (PRRC) services under MDR and IVDR. Their experts have at least four years of professional experience in regulatory affairs or QMS related to medical devices. With over 20 years of industry experience in the IVD and Medical Device industry, Qarad provides an outsourced center of excellence for quality and regulatory matters. The designation process is well structured and based on intensive involvement of the designated PRRC in the company's processes. Small and micro companies (fewer than 50 employees, turnover/balance sheet under €10M) may outsource the PRRC role to Qarad.
Additional eu_ar Details
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Belgium
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
The certificate for ISO 13485:2016 covers 'The sales and provision of consulting, training, authorized representative, performance evaluation and e-labeling services for the medical devices industry.'
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
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