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Expert Regulatory & Quality Support for MedTech Start-ups (1)

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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Talk to a MedTech Expert

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.

 

Explore the start-up journey
Expert Regulatory & Quality Support for MedTech Start-ups (2)

 

Where are you in your start-up journey?

Whether you’re shaping your first prototype or preparing for launch, every stage comes with unique challenges—and opportunities. Explore how we support you across the full medical device lifecycle.

MedTech Startups timeline (1)

Start-up success pillars

Start-ups face tight timelines, complex regulations, and pressure to prove value fast. A solid strategy from day one helps you avoid roadblocks, win investor trust, and accelerate your route to market. But where should you focus first? These four pillars form the foundation of successful MedTech ventures.

Funding & Investment

Funding & Investment

Convince investors with a solid regulatory strategy, QMS plan, and realistic clinical roadmap.

Regulatory & Compliance

Regulatory & Compliance

Need to tackle IVDR, ISO 13485, or technical documentation? We’ll guide you through every requirement — step by step.

Product Development

Product Development

From feasibility to design control, we help you align with standards and get your documentation right from the start.

Go-to-Market Strategy

Go-to-Market Strategy

Finalizing your tech file? Preparing for audits? Planning PMCF? We’ll help you launch with confidence.
Expert Regulatory & Quality Support for MedTech Start-ups-1

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.
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Facilitate Product Development

A structured approach keeps your development process aligned with safety and quality standards — making it easier to design, test, and document your device effectively.

Improve Efficiency & Reduces Risk

By planning for compliance from the start, you avoid last-minute surprises, reduce rework, and stay focused on innovation.

Support Funding & Partnerships

Investors and partners look for teams with a clear path to market. Early regulatory and quality planning makes your start-up more attractive and trustworthy.

Prepare for Audits & Inspections

Health authorities will inspect your systems. If your documentation is in order early on, audits become smoother and less disruptive.

Mitigate Long-Term Costs

Catching issues early is far cheaper than fixing them later. Avoiding non-compliance or product recalls saves significant time and money.

Enable Faster Time to Market

When your regulatory and clinical strategy is mapped out early, you avoid delays and can move through the approval process with confidence.

Lays Groundwork for Global Expansion

Many frameworks (like ISO 13485, CE, FDA) are internationally recognized. Setting up with global standards from the start helps you scale later without costly adjustments.

Align Your Team Around a Clear Roadmap

With a regulatory and quality strategy in place early on, everyone—from R&D to investors—knows what to expect. It creates alignment, improves decision-making, and keeps your project on track.

How we help start-ups succeed

From first concept to market launch, we tailor our services to your stage, your needs, and your speed.

IMPD Clinical Trials key quality considerations for regulatory success

Quality Assurance

Build quality in from day one.

  • Design a right-sized QMS that grows with you

  • Align early with ISO 13485 and industry best practices

  • Prepare for audits and inspections without stress

Set up your quality foundation
RA Update - New UK Clinical Trials Regulations Key Updates and What They Mean

Clinical Services

Plan smart clinical strategies that fit your timeline and budget.

  • Choose the right clinical pathway from the start

  • Get help with protocols, site selection, and monitoring

  • Generate evidence without overcomplicating things

Explore clinical support for start-ups
Regulatory Affairs Our Services - QbD Group

Regulatory Affairs

Navigate IVDR, MDR, and FDA requirements with confidence.

  • Map out your route to market step by step

  • Get hands-on help with tech files, submissions & gap assessments

  • Legal representation, PRRC & post-launch planning included

See how we guide you through compliance
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Software & SaMD

Build compliant, scalable software from sprint one.

  • Apply IEC 62304 (and 14971/81001-5-1) without slowing delivery

  • Plan & document V&V, automation, and cybersecurity from the start

  • Integrate DevOps and QMS so code, DHF, and releases stay in sync

Accelerate your SaMD roadmap

Our offerings for Medical Devices in

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QPPV / Local Representative

QPPV / Local Representative

Ensure global compliance with QbD's QPPV and Local Representative services. Gain expert support for safety oversight and regulatory obligations worldwide.
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Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

Literature Monitoring Search Solutions & Alerts and a Set of Medical Information Solutions

Stay compliant with QbD Group's Literature Monitoring Services. Detect safety signals, ensure timely reporting, and enhance your vigilance strategy.
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ICSR Management

ICSR Management

Maintain compliance and protect patient safety with QbD's expert management of individual case safety reports (ICSRs). Simplify safety reporting processes for clinical...
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Pharmacovigilance & Certified Blended Training

Pharmacovigilance & Certified Blended Training

Empower your team with our certified pharmacovigilance training. Tailored courses to ensure compliance, mitigate risks, and enhance operational excellence.
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Operational Software Compliance

Operational Software Compliance

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

Digitalization

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

One partner. One roadmap. From idea to market — fast, smart, and ready for scale.
Talk to a QbD MedTech Expert
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Full lifecycle support

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Scalable expertise

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Global team of 700+ experts

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20+ years of experience

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Get in touch

Partner with QbD Group to ensure your medical device meets the highest standards of quality and compliance. Fill out the form and our experts will help you navigate the development process with ease and efficiency.
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Resources

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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.
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