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Expert Regulatory & Quality Support for MedTech Start-ups
Bringing your MedTech innovation to life? We help you navigate regulatory, clinical, and quality challenges from day one.
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Avoid the start-up pitfalls
Bringing a MedTech product to market is complex. From defining your product's intended use to navigating regulatory approval, there are many steps — and many risks.
It’s natural for start-ups to prioritize product development and funding. But with so much complexity involved, crucial areas like regulatory planning, clinical strategy, and quality systems are often missed, and that can lead to major roadblocks down the line.
Common pitfalls we see:
- Delayed approvals due to missing documentation
- Rework from misaligned development and regulatory strategy
- Clinical studies that don’t support intended claims
- Lost investor confidence due to lack of regulatory readiness
Start-ups that build in quality and compliance early are more likely to reach the market efficiently.
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Why start early with your regulatory, clinical, and quality strategy?
Building a foundation with QMS and regulatory strategies early on is an investment in long-term stability, growth, and success. It helps to avoid costly mistakes, ensures a faster route to market, and builds trust with stakeholders. Ultimately, it positions your company to meet regulatory requirements, maintain high-quality standards, and scale successfully.
How we help start-ups succeed
From first concept to market launch, we tailor our services to your stage, your needs, and your speed.
Our offerings for Medical Devices in
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Why QbD Group?
YOUR START-UP PARTNER IN MEDTECH COMPLIANCE
Bringing a medical device to market is complex, but you don’t have to do it alone. QbD Group offers full-spectrum support: from regulatory strategy and QMS design to clinical validation and software compliance.
Our experts don’t just know the rules — we help you apply them pragmatically and cost-effectively at every step.
We understand the pressures start-ups face. That’s why we deliver agile, tailored guidance that fits your pace, your budget, and your growth plans.
Our experts don’t just know the rules — we help you apply them pragmatically and cost-effectively at every step.
We understand the pressures start-ups face. That’s why we deliver agile, tailored guidance that fits your pace, your budget, and your growth plans.
One partner. One roadmap. From idea to market — fast, smart, and ready for scale.
Full lifecycle support
Scalable expertise
Global team of 700+ experts
20+ years of experience
Resources
Case study
Case study
Case study
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.
Case study
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Case study
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