Qarad (UK Responsible Person)
UK Responsible Person Association
The UK Responsible Person Association (UKRPA) is an alliance of providers of UK Responsible Person services, promoting professional conduct and competence among its members.
The UK Responsible Person Association (UKRPA) was established in December 2020 as an alliance for companies and individuals acting as UK Responsible Persons under the Medical Devices Regulations 2002. The association's primary goal is to promote professional conduct and competence within the field. While the regulations do not specify qualifications, the responsibilities of a UKRP necessitate a strong understanding of medical device regulatory requirements and relevant experience. UKRPA comprises founding members who are specialists in providing regulatory services to medical device manufacturers globally, bringing extensive experience akin to the UKRP role. The association welcomes all companies and individuals serving as UKRPs, aiming to foster professionalism and excellence. They actively cooperate with the MHRA to improve transparency and understanding of regulatory requirements. For those seeking a professional UK Responsible Person, the association's Members page provides contact details. General inquiries and membership applications can be directed to enquiries@ukrp-association.org.
About
**Who they are**
Qarad (UK Responsible Person) is a consulting company with over 30 years of experience in the IVD and Medical Device industry, specializing in Regulatory Affairs and Quality Systems. They are part of the QbD Group and are ISO 13485:2016 and ISO 27001 certified.
**Expertise & scope**
* Regulatory Affairs and Quality Systems for IVD and Medical Device industry.
* Development of eIFU services, offering a single supplier solution for distributing technical documentation via a digital platform.
* Services include IVD Technical Documentation, Post-Market Surveillance, Performance Study Documentation, Representative Services, and Medical Writing.
* Deep knowledge of IVDs and related regulations, with consultants experienced in fields such as immunoassays, next-generation sequencing, PCR tests, and flow cytometry.
* Act as a UK Responsible Person (UKRP) for manufacturers established outside the UK, handling registration of devices and acting as a point of contact.
**Reputation / proof points**
* Experienced in the IVD and MD field since 1986.
* ISO 13485:2016 certified.
* ISO 27001 certified.
* Member of the UK Responsible Person Association (UKRPA).
Qarad (UK Responsible Person) is a consulting company with over 30 years of experience in the IVD and Medical Device industry, specializing in Regulatory Affairs and Quality Systems. They are part of the QbD Group and are ISO 13485:2016 and ISO 27001 certified.
**Expertise & scope**
* Regulatory Affairs and Quality Systems for IVD and Medical Device industry.
* Development of eIFU services, offering a single supplier solution for distributing technical documentation via a digital platform.
* Services include IVD Technical Documentation, Post-Market Surveillance, Performance Study Documentation, Representative Services, and Medical Writing.
* Deep knowledge of IVDs and related regulations, with consultants experienced in fields such as immunoassays, next-generation sequencing, PCR tests, and flow cytometry.
* Act as a UK Responsible Person (UKRP) for manufacturers established outside the UK, handling registration of devices and acting as a point of contact.
**Reputation / proof points**
* Experienced in the IVD and MD field since 1986.
* ISO 13485:2016 certified.
* ISO 27001 certified.
* Member of the UK Responsible Person Association (UKRPA).
Additional information
Qarad (UK Responsible Person) provides services to manufacturers outside the UK who need to comply with UK regulations following the UK's departure from the European Union. The UK Responsible Person (UKRP) is a designated individual or entity established in the UK who acts on behalf of the manufacturer for specific regulatory tasks. This includes registering devices with the UK's electronic system and serving as the primary contact for regulatory authorities. Qarad's expertise in IVD and Medical Device regulations ensures that manufacturers can meet these new obligations effectively. Their services are designed to support compliance with the UK MDR, including the new registration requirements that apply after the transition period.
Key Highlights
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Experienced in the IVD and MD field since 1986.
Source
“Experienced in the IVD and MD field since 1986”
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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 certified, demonstrating commitment to information security management.
Source
“ISO 27001 Certified”
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Provides UK Responsible Person (UKRP) services for manufacturers outside the UK.
Source
“The UKRP has been defined as a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom”
Certifications & Trust Signals
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ISO 13485:2016 certified.
Source
“Qarad is an ISO 13485:2016 certified company.”
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ISO 27001 certified.
Source
“ISO 27001 Certified”
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Member of the UK Responsible Person Association (UKRPA).
Source
“The UK Responsible Person Association (UKRPA) is an alliance of providers of UK Responsible Person services”
Buyer Snapshot
Best for
- Manufacturers outside the UK needing a UK Responsible Person.
- Companies in the IVD and Medical Device sector.
How engagement typically works
- Consulting and advisory services.
- Acting as a designated UK Responsible Person.
Typical deliverables
- UK Responsible Person services.
- IVD Technical Documentation.
- Post-Market Surveillance support.
- Performance Study Documentation.
- eIFU services.
Good to know
- Best when manufacturers are established outside the United Kingdom.
HQ:
Birmingham, UK
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
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
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
United Kingdom
Onboarding Steps
Manufacturers shall designate only one UK Responsible Person. The UKRP will take on the responsibility for the manufacturer to register the devices with the electronic system set-up by the Secretary of State and will act as the point of contact for that manufacturer.
