Regulatory Affairs for In Vitro Diagnostics

Expert IVDR compliance from strategy to submission

Ensure your in vitro diagnostic products meet evolving regulatory standards worldwide. Our experts support you in building robust, compliant files that stand up to scrutiny.

Offerings

What we offer20

Authorised Representative Services

If you want to sell your product in countries other than your own, it is important to consider the local regulations.

Authorized Representative (CH-REP)

Qarad Suisse S.A. – part of the QbD Group – is an independent partner that can act as your Swiss Authorized Representative (CH-REP).

Authorized Representative (EU-REP)

QbD Group, supported by the Qarad experts, is an independent partner that can act as your Authorized Representative (EC-REP).

Coaching & Training

Tailored regulatory training programs to build practical MDR/IVDR competence within your medical device and IVD teams.

IVDD to IVDR Transition Support

Get expert support for your IVDD to IVDR transition. From gap assessment to submission, QbD ensures a smooth, compliant path to certification.

IVDR Compliance & CE Certification

Strategic IVDR compliance for secure and sustainable EU market access. End-to-end support from regulatory roadmap to CE certification.

Landing in Europe

Accelerate your entry into the European life sciences market with QbD Group's expert regulatory support, compliance solutions, and strategic guidance.

Legal Representative

If the sponsor of a performance study is not established in the European Union, we can ensure that a natural or legal person is established in the Union as its legal representative.

Liaison with Notified Bodies

Strategic management of Notified Body interactions throughout the conformity assessment process for medical devices and IVDs.

Lifecycle Management

Our experts will accompany you throughout the whole Product Life Cycle Management process – from its conception, through design and manufacture, to service and disposal.

Materiovigilance

Systematic monitoring and reporting of incidents related to medical devices and IVDs, including FSCA management and trend reporting.

Notified Body Submissions

Navigating the submission process can be daunting, but you don't have to do it alone. Our experts can prepare and submit your application to the notified body.

Person Responsible for Regulatory Compliance (PRRC)

Are you looking for a person responsible for regulatory compliance (PRRC) for your IVDs or Medical Devices? We provide PRRC services to IVD/MD manufacturers with fewer than 50 employees.

Pharmacovigilance

QbD Group offers a full range of pharmacovigilance services to ensure your products meet compliance standards while safeguarding patient safety.

Post-Market Surveillance

Post-Market Surveillance (PMS) is a vital component of maintaining product safety and efficacy once your IVD/Medical Device is on the market.

RA Design & Development

Embark on your journey by conceptualizing your IVD or MD. We will assist you in navigating the intricate landscape of design and development.

RA Strategy for MD & IVD

Our tailored and strategic approach will help guide your organization through the complexities of regulatory frameworks.

Regulatory Procedures

There are various procedures to register pharmaceutical drugs, depending on the type of drug and your intended route to market. Our experts will lead you to the right path.

Technical Documentation

We can support the writing and compilation of IVDR/MDR-compliant technical documentation in line with your notified body's specific expectations.

UK Responsible Person (UKRP)

Qarad UK Ltd. – part of the QbD Group – is an independent partner that can act as your UK Responsible Person (UKRP).

Why QbD Group

Your trusted partner

QbD Group's Regulatory Affairs team combines deep industry expertise with a pragmatic, hands-on approach. We help life sciences companies navigate complex European regulatory landscapes efficiently — from initial strategy through post-market compliance.

Cross-industry expertise

our regulatory specialists cover Pharma, Biotech, Medical Devices, IVD, and Combination Products under one roof.

Strategic regulatory planning

we align your regulatory pathway with commercial objectives to accelerate time-to-market.

Proven track record

with thousands of successful submissions and dossier management projects across Europe, we deliver results you can count on.

Scalable support

from a single regulatory question to full outsourced regulatory operations, we adapt to your needs.

Let's talk Regulatory Affairs

From regulatory strategy to product approval, our experts are ready to guide you through every step.