Qualification & Validation
Qualification & Validation
Quality Assurance
Quality Assurance
Regulatory Affairs
Regulatory Affairs
Clinical
Clinical
Lab Services
Lab Services
Vigilance
Vigilance
Software Solutions & Services
Software Solutions & Services
Tox green
Toxicology
Pharma (2)
Pharma & Biotech
Medical Devices (2)
Medical devices
IVD (2)
In vitro diagnostics
Search QbD Group
  • There are no suggestions because the search field is empty.
Authorised Representative Services

Authorised Representative Services

Understanding the regulatory landscape for In Vitro Diagnostics (IVDs) and medical devices (MDs) in international markets can be complex.

Each country imposes unique standards, often requiring the appointment of an Authorised Representative to ensure local compliance. These complexities can create barriers to market entry and ongoing sales, demanding a precise and knowledgeable approach.

Discover how our tailored in-country representative services for IVDs and MDs can help you achieve global market success.

Read more

 

Unlock the doors to European, UK and Swiss markets

KEY TO SELLING YOUR DEVICE ABROAD

 

Do you require representative services to sell your Medical Devices and/or IVDs outside of your own country?


Qarad – part of the QbD Group – serves as an independent partner capable of acting as your Authorized Representative (EC-REP), Swiss Authorized Representative (CH-REP), or UK Responsible Person (UKRP).


Uncertain about the necessity of representative services for your Medical Devices and/or IVDs? Please refer to our overview below.

 

Authorized Representative Service overview

Select your requested service

Authorized-Representative-EC-REP-QbD-Group

EC-REP

When you are a manufacturer that wants to enter the European Union.
Learn more
UK-Responsible-Person-UKRP-QbD-Group

UKRP

If you are a manufacturer that wants to enter the United Kingdom.
Learn more
Swiss-Authorized-Representative-CH-REP-Services-QbD

CH-REP

For manufacturers that want to enter Switzerland.
Learn more
circles

Why partner with QbD Group?

The Qarad experts have been active for many years as a European Authorized Representative for over one hundred different companies, and build on the regulatory and technical competence of the team. We can fulfill your need for representative services by acting as: 

Contact us
In-country representative service - Regulatory Affairs - QbD Group (1)

Related content

preview_image
Case study

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.
Read more
preview_image
Whitepaper

Medical Device Regulation (MDR) Checklist

Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.
Read more
preview_image
Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.
Read more
preview_image
Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!
Read more
preview_image
Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.
Read more
preview_image
Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.
Read more
preview_image
Whitepaper

Mobile health on the rise: exploring the regulatory landscape for reimbursement

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.
Read more
preview_image
Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.
Read more
preview_image
Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.
Read more
preview_image
Webinar

Technical Documentation Essentials for Medical Device Software

Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.
Read more
preview_image
Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.
Read more
preview_image
Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.
Read more
preview_image
Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.
Read more
preview_image
Webinar

Post-Market Surveillance Requirements for Medical Devices and IVDs

Learn about post-market surveillance requirements under MDR and IVDR regulations. Gain insights from industry experts in this on-demand webinar.
Read more
preview_image
Whitepaper

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

Discover the key role of Regulatory Affairs in pharma and how Regulatory Affairs teams support product lifecycle management in this whitepaper. Download now.
Read more
preview_image
Webinar

3D Printing in the Healthcare World

Explore the challenges and opportunities of 3D printing in healthcare, featuring expert insights on regulations, pitfalls, and efficiency.
Read more
preview_image
Webinar

IVDR Extension Explained: Tips & Strategies

Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.
Read more
preview_image
Whitepaper

Innovations in ATMP: state of the industry in 2024

This whitepaper explores the innovations in ATMP and solutions in detail, with a focus on the current landscape as of April 2024. Download now.
Read more
preview_image
Case study

The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.
Read more
preview_image
Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
Read more
preview_image
Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.
Read more
preview_image
Webinar

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Learn about the Medical Device CE Certification Pathway, from classification to conformity assessment by a Notified Body. Join our webinar on demand.
Read more
preview_image
Case study

Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.
Read more
preview_image
Case study

Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.
Read more
Discover all

 

contact-mail

Get in touch

Contact us for more information or request a free, no-obligation proposal.

RA_Get in touch