Regulatory Affairs | Our Services - QbD Group

Regulatory Affairs Services

Your regulatory expert for in vitro diagnostics

Get your in vitro diagnostic (IVD) to market with confidence through expert Regulatory Affairs support. From strategy to product approval, we offer tailored services to navigate regulatory requirements and meet the applicable standards.

Whether it’s compiling technical documentation, managing submissions, or coordinating with regulatory bodies, we handle the details so you can focus on innovation. Keep your IVD business compliant and competitive with QbD Group by your side.

Discover our regulatory services

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Our offerings for Regulatory Affairs in IVD

Lifecycle Management

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

Regulatory Intelligence

Regulations and standards may change every now and then, and manufacturers must be aware of those changes. Our consultants keep you on track at all times.

RA Strategy for MD & IVD

Our tailored and strategic approach will help guide your organization through the complexities of regulatory frameworks, ensuring a smooth journey from development to...

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, ensuring that your product...

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...

Technical Documentation

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

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, ensuring...

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. We will assist you in...

Authorised Representative Services

If you want to sell your product in countries other than your own, it is important to consider the local regulations. Find out more about our in-country representative...

Person Responsible for Regulatory Compliance (PRRC)

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

Authorized Representative (EU-REP)

Are you looking for an Authorized Representative (EC-REP) for your medical devices and/or IVDs?QbD Group, supported by the Qarad experts, is an independent partner that...

Authorized Representative (CH-REP)

Are you looking for a Swiss Authorized Representative (CH-REP) for your medical devices and/or IVDs? Qarad Suisse S.A. – part of the QbD Group – is an independent...

UK Responsible Person (UKRP)

Are you a medical device and/or IVD manufacturer based outside the UK, but selling in the UK? If so, you need aUK Responsible Person (UKRP). Qarad UK Ltd. – part of the...

Linguistic Review

QbD Group offers expert linguistic review services to meet tight deadlines and regulatory requirements.

Landing in Europe

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

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.

Pharmacovigilance

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

Get in touch

IVD regulatory requirements can be demanding and highly specialized. Our team is here to help you build strong, compliant submissions with confidence. Connect with us today and ensure your diagnostics meet international regulatory expectations.