• There are no suggestions because the search field is empty.
In-country Representative service - Regulatory Affairs - QbD Group

In-County 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.

 

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.
UK-Responsible-Person-UKRP-QbD-Group

UKRP

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

CH-REP

For manufacturers that want to enter Switzerland.
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: 

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

Related content

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.
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.
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!
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.
preview_image
Blog

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) under the MDR: Ensuring safety and performance

With the introduction of the Medical Device Regulation (MDR), the...
preview_image
Blog

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

It shouldn’t be a surprise that today, “Near-Patient Testing (NPT)” and...
preview_image
Blog

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

In the European regulatory landscape, conducting performance studies for in...
preview_image
Blog

How to define your Clinical Performance Strategy?

1. Start with a clear intended purpose A strong clinical...

 

contact-mail

Get in touch

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

RA_Get in touch