UK Responsible Person
QCS International
QCS International, a subsidiary of PHSC plc, is a registered UK Responsible Person (UK RP) with the Medicines and Healthcare Products Regulatory Agency (MHRA). They specialize in assisting manufacturers located outside the UK to export medical devices into the UK market. With over 15 years of experience in medical device regulations, QCS International ensures compliance with the amended UK Medical Devices Regulations 2002 (UK MDR 2002) and post-Brexit regulatory requirements. Their service is cr
The UK Responsible Person (UK RP) for this directory listing is the Home Office. As a key UK government department, the Home Office is responsible for a wide range of public services including immigration, security, and law and order. Their media presence is managed through official channels, including the 'Home Office in the media' blog, which provides updates on home affairs-related stories, official statements, and ministerial comments. This blog serves as a primary source for news reviews, responses to breaking news, and rebuttals to inaccurate reports. The Home Office also maintains a dedicated media enquiry service for journalists. This service provides a news desk for inquiries, operating during specific hours with an out-of-hours option for urgent matters. It is important to note that the press office is unable to answer calls from members of the public, directing them to alternative contact methods for specific services like UK Visas and Immigration or general public inquiries.
About
**Who they are**
UK Responsible Person, operating as QCS International, is a subsidiary of PHSC plc and a registered UK Responsible Person with the MHRA. Established in 1987, they have over 15 years of experience in medical device regulations.
**Expertise & scope**
* Assisting manufacturers located outside the UK to export medical devices into the UK market.
* Ensuring compliance with the amended UK Medical Devices Regulations 2002 and post-Brexit regulatory requirements.
* Specializing in medical device projects and ISO management systems.
* Providing consultancy for system development, certification, and auditing services.
* Offering services such as Outsource System Manager, Safety Management, and Legal Compliance.
**Reputation / proof points**
* Over 15 years of experience in medical device regulations.
* Established in 1987, QCS International is a leading management system consultancy and training specialist.
* Consultants are members of CQI and registered management system auditors with IRCA.
UK Responsible Person, operating as QCS International, is a subsidiary of PHSC plc and a registered UK Responsible Person with the MHRA. Established in 1987, they have over 15 years of experience in medical device regulations.
**Expertise & scope**
* Assisting manufacturers located outside the UK to export medical devices into the UK market.
* Ensuring compliance with the amended UK Medical Devices Regulations 2002 and post-Brexit regulatory requirements.
* Specializing in medical device projects and ISO management systems.
* Providing consultancy for system development, certification, and auditing services.
* Offering services such as Outsource System Manager, Safety Management, and Legal Compliance.
**Reputation / proof points**
* Over 15 years of experience in medical device regulations.
* Established in 1987, QCS International is a leading management system consultancy and training specialist.
* Consultants are members of CQI and registered management system auditors with IRCA.
Additional information
QCS International provides a comprehensive range of consultancy services to help establish, implement, and maintain management systems, with a particular focus on medical device projects. They work with clients to develop integrated solutions aligned with unique operational needs, fostering continuous improvement and sustained compliance. Their approach involves assigned consultants supported by project leads to track progress and provide access to expert resources. Services extend to training courses, including eLearning and online portals, covering various ISO standards and safety requirements.
Key Highlights
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Registered UK Responsible Person with the MHRA.
Source
“QCS International, a subsidiary of PHSC plc, is a registered UK Responsible Person (UK RP) with the Medicines and Healthcare Products Regulatory Agency (MHRA).”
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Over 15 years of experience in medical device regulations.
Source
“With over 15 years of experience in medical device regulations, QCS International ensures compliance with the amended UK Medical Devices Regulations 2002 (UK MDR 2002) and post-Brexit regulatory requirements.”
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Specializes in assisting non-UK manufacturers export to the UK market.
Source
“They specialize in assisting manufacturers located outside the UK to export medical devices into the UK market.”
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Established in 1987 as a management system consultancy and training specialist.
Source
“Established in 1987, QCS International has grown to become one of the UK’s leading management system consultancy and training specialists.”
Certifications & Trust Signals
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Consultants are members of CQI and registered management system auditors with IRCA.
Source
“All of our consultants are members of CQI and all are registered management system auditors with IRCA.”
Buyer Snapshot
Best for
- Manufacturers outside the UK seeking to export medical devices.
- Companies needing assistance with UK MDR 2002 compliance.
- Organizations requiring ISO management system development and certification.
How engagement typically works
- Collaborative consultancy with assigned project leads.
- Tailored solutions based on unique operational needs.
- Support for establishing, implementing, and maintaining management systems.
Typical deliverables
- UK Responsible Person services.
- ISO management system development and certification.
- Auditing services.
- Outsourced system management.
- Regulatory compliance assistance.
Good to know
- Best when requiring specialized expertise in UK medical device regulations.
HQ:
United Kingdom, UK
Languages:
English
Timezones:
GMT
Claim status:
Listed
Services & Capabilities
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Jurisdictions:
UK
Countries:
UK
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Supports GB:
Yes
Supports NI:
Yes
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
Not explicitly stated, but expertise in medical device projects is mentioned.
Supports GB
Yes
Vigilance Support
Not explicitly stated.
Post Market Support
Not explicitly stated.
UK Entity Country
Scotland
Onboarding Steps
The website mentions consultancy services to help establish, implement, and maintain management systems, with assigned consultants and project leads assisting in delivery.
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