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Where compliance, efficiency, and innovation drive success

Don’t be late to the digital transformation of the life sciences industry. QbD Group leverages deep expertise in business processes, regulatory requirements, and IT.

We provide tailored software solutions and comprehensive services to help you strike the right balance between compliance and business efficiency. Stay ahead of the online revolution and bring your products to market swiftly and successfully.

Expertise

Your digital challenges are in safe hands with our expertise that bridges business processes, regulatory gaps, and IT.

Technology agnostic approach

Our approach ensures that your unique needs dictate the solutions we provide, not the limitations of a specific technology.

Full life sciences coverage

Our solutions and services cover all life sciences areas from medical devices (MD) and in vitro diagnostics (IVD) to ATMPs and medicinal products.

Full lifecycle support

We help you navigate the complexities of digital transformation with confidence and agility, ensuring your whole journey is as swift and successful as possible.

Market trends & challenges

In the rapidly evolving digital landscape, life sciences organizations face mounting regulatory requirements and increasing pressure to optimize efficiency. Software validation, data integrity, and system digitization are now critical to ensuring compliance while driving operational improvements.
 
At the same time, businesses must adapt to new technologies and address cybersecurity risks without compromising system reliability. The shift toward cloud-based platforms and automation creates both opportunities and challenges, requiring expertise and a future-focused strategy.
 
QbD Group helps you navigate these complexities with tailored software solutions that prioritize compliance, streamline processes, and prepare your organization for tomorrow’s demands.
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Medical Device Software Compliance

Medical Device Software Compliance

Our service offers a tailor-made framework for medical device software compliance, ensuring adherence to MDR, IVDR, ISO13485, ISO14791, and other key standards. We...
AI/ML Compliance

AI/ML Compliance

Looking for guidance while developing software including AI-models? QbD offers AI/ML compliance support helping you be compliant with the latest standards and...
Data Governance

Data Governance

QbD Group offers data governance support, helping you comply with the latest regulations and shorten your path to market.
Digitalization

Digitalization

Our expertise in software implementation and IT partnerships ensures a seamless transition from traditional methods to advanced digital solutions, allowing you to...
Software Validation, Central IT Systems

Software Validation, Central IT Systems

Ensure your software solutions meet regulatory standards with our comprehensive Software Validation services. We specialize in Computer System Validation (CSV) to...
Data Integrity

Data Integrity

Ensure your data's accuracy and consistency with our tailored data integrity services. We provide expert guidance on complying with the latest regulatory standards,...
Software Implementations

Software Implementations

Transform your life science organization with our expert software implementation services. Our team ensures seamless integration and compliance, delivering customized...
IT Infrastructure Qualification

IT Infrastructure Qualification

Ensure your IT systems meet regulatory standards with our IT infrastructure qualification services. We specialize in validating on-premises and cloud-based systems to...
Paperless Validation

Paperless Validation

Transform your validation process with our Paperless Validation service, offering a digital, efficient, and error-free solution for regulated industries. Say goodbye to...
Operational Software Compliance

Operational Software Compliance

Need seamless operational software compliance? QbD ensures your systems meet industry regulations, enhancing data security and reliability.

Our software solutions

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IFUcare

Discover how our eIFU service can help IVD and medical device manufacturers leave paper IFUs behind, saving costs, simplifying processes, and ensuring regulatory compliance. Developed by regulatory experts, we focus on compliance and risk management.
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Scilife™

From document control and training to CAPAs and AI-driven KPIs, Scilife ensures full traceability, integration, and compliance. Its intuitive interface makes it easy to get started, and its powerful features make staying on top of quality a breeze.
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Why QbD Group?

QbD Group provides trusted software solutions to life sciences organizations worldwide. With over a decade of experience, our team delivers compliance, efficiency, and innovation through tailored strategies that meet your unique needs.

What sets us apart?

  • Proven expertise: Over 10 years of experience in life sciences software solutions.

  • Tailored support: Customized strategies to meet your organization’s goals.

  • Global presence: Compliance expertise across international markets.

  • Full lifecycle services: From implementation to ongoing maintenance, we’ve got you covered.

Partner with QbD Group for software solutions that drive success at every stage.

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+10 years of experience

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Full lifecycle support

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Global presence

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Best Managed Company

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Get in touch

Have a question? Let's talk Software Solutions!

Our team of experts at QbD Software Services & Solutions is here to answer your questions, provide insights, or discuss how we can support your project. Whether you're looking to optimize compliance, streamline workflows, or harness the power of data in life sciences, we’re ready to help. Share your details, and we’ll be in touch shortly!

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