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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.

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.

 

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.

Medical device Life Cycle - FINAL - 20250618

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.

Product Development

Product Development

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

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.

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.

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

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

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

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.
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.
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...
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.
Operational Software Compliance

Operational Software Compliance

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

Digitalization

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

Facility Qualification

Confirm that your facilities and HVAC (heating, ventilation, and air conditioning), cleanrooms, and monitoring systems, meet predetermined specifications and regulatory...
Process & Product Support

Process & Product Support

In today’s competitive marketplace, optimization of processes and products can make a real difference. Working with QbD Group, you can trust that your processes and...
Tracking Adverse Drug Reactions

Tracking Adverse Drug Reactions

Monitor and address adverse drug reactions with precision. QbD Group’s safety database solutions support regulatory compliance while prioritizing operational...
Vigilance and Pharmacoviglance Hotline Services

Vigilance and Pharmacoviglance Hotline Services

Emergencies don’t sleep and neither does our support. The One Vigilance hotline is open 24/7 all year round.
EudraVigilance Medicinal Product Dictionary (XEVMPD)

EudraVigilance Medicinal Product Dictionary (XEVMPD)

Achieve XEVMPD compliance effortlessly with QbD's expertise. Simplify your regulatory submissions and maintain up-to-date safety profiles for consistent, safe medicinal...
Safety Reporting & Signal Detection

Safety Reporting & Signal Detection

Optimize your aggregate safety reporting with customized solutions from QbD. Manage risks, meet regulatory standards, and uphold patient safety with tailored strategies...
Project Management

Project Management

Coordinate pharmacovigilance projects seamlessly with QbD’s project management expertise. Drive safety goals, meet compliance requirements, and improve operational...
Regulatory Intelligence

Regulatory Intelligence

Stay ahead of evolving regulations with QbD’s regulatory intelligence services. Anticipate changes, address potential risks, and streamline compliance with informed,...
Strategic Planning

Strategic Planning

Align safety and business goals with QbD’s strategic planning services. Build a clear roadmap for compliance while maximizing value and operational efficiency for your...
Safety Signal Program

Safety Signal Program

Enhance patient safety with QbD Group’s Safety Signal Program. Detect risks early, ensure compliance, and build trust with proactive safety solutions.
Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Pharmacovigilance QMS & Pharmacovigilance System Master File (PSMF)

Streamline your pharmacovigilance compliance with QbD’s tailored QMS & PSMF services. Ensure efficiency, audit readiness, and global regulatory alignment.
Pharmacovigilance (PV) Audits

Pharmacovigilance (PV) Audits

Ensure compliance & inspection readiness with QbD’s certified PV audits, mock inspections, and ISO services. Strengthen your pharmacovigilance systems now.
QMS Implementation

QMS Implementation

Optimize your quality management system with QbD's tailored QMS Setup services. Build a smart, scalable system that aligns with regulatory standards and drives value.
QMS Remediation & Support

QMS Remediation & Support

Achieve operational excellence with QbD's QMS Remediation & Support services. Address gaps, sustain certification, and maintain smooth operations seamlessly.
QA Outsourcing

QA Outsourcing

Simplify compliance and reduce costs with QbD Group’s Outsourced QA solutions. Tailored support to manage your QMS or specific quality functions effectively.
QA Audits & Remediation

QA Audits & Remediation

Audits are viewed as a necessity. We strive to see any audit as an opportunity to gain more insights into the company itself and the quality management system, which...
Regulatory Intelligence

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.
Clinical Trial Operations

Clinical Trial Operations

Discover QbD Group's expertise in clinical study operations. Tailored support for successful studies and robust clinical evidence. Let's collaborate.
Medical Writing for Medical Devices

Medical Writing for Medical Devices

Our expert team of knowledgeable writers will be happy to develop the right document for your needs, from the early phases to post-approval.
Clinical Regulatory Services

Clinical Regulatory Services

We help sponsors and manufacturers who want to perform a study in Europe (and beyond) to navigate through the MDR requirements to make sure their study gets approved by...
Post-Market Clinical Follow-up

Post-Market Clinical Follow-up

Ensure EU MDR 2017/745 compliance with thorough pre-market and post-market processes. Validate device safety with robust data and proactive Post-Market Surveillance...
Clinical Strategy Support

Clinical Strategy Support

We can assist manufacturers by assembling a team of experts with diverse knowledge and backgrounds, such as physicians and clinical experts, to ensure all necessary...
Data Management and Analysis

Data Management and Analysis

Clinical data management leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. The clinical data manager oversees the...
Clinical Safety Management

Clinical Safety Management

Ensure safety and compliance in clinical trials with QbD Group’s expert Clinical Safety Management solutions. Tailored to meet your trial needs.
Clinical Quality Services

Clinical Quality Services

Looking for support in setting up your clinical Quality Management System (QMS), revision of Standard Operating Procedures (SOPs) or an audit? QbD Clinical is your...
Clinical Expert Services

Clinical Expert Services

Are you looking for research professionals to support your clinical study under your own management or in an FSP (functional service provider) model? Our expert team of...
RA Strategy for MD & IVD

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

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...
Technical Documentation

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

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

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

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)

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...
Experts in Medical Device Clinical Trials

Experts in Medical Device Clinical Trials

Expert support for medical device clinical trials, from strategy to post-market. Explore our services and real-world client success stories.
Comprehensive Medical Information Services

Comprehensive Medical Information Services

Enhance patient safety and product trust with QbD Group's expert medical information services, ensuring timely, accurate responses and compliance throughout your product...
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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.
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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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Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.
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Case study

Enhancing data integrity & aseptic manufacturing compliance

QbD Group helped a leading medical tech company improve MDR compliance and enhance aseptic manufacturing for long-term regulatory readiness.
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Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.
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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.
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Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.
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Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.
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Helping Abraca BioSystems to obtain ISO 13485 certification

QbD Group helped Abraca Biosystem gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.
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Help BioLizard build their Quality Management System

QbD Group helped BioLizard document the fundamental processes of their QMS and enabled them to continue building it on their own.
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Supporting Oncomfort in developing and certifying their ISO 13485 QMS

QbD Group helped Oncomfort quickly implement and certify an ISO 13485 compliant Quality Management System.
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Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.

Connect with us at these events

Industry
Service

July

27.07 - 31.07

In Vitro Diagnostics

ADLM

Chicago (IL), USA

August

29.08 - 01.09

Medical Devices

ESC Congress

Madrid, Spain

September

07.09 - 11.09

Medical Devices

LSI Europe

London, UK

17.09 - 18.09

Pharma & Biotech

Farmaforum

Madrid, Spain

23.09 - 23.09

Pharma & Biotech

BioWin day

Namur, Belgium

25.09 - 25.09

Pharma & Biotech
Medical Devices
In Vitro Diagnostics

QbD Group x Gevers Roadshow: Liège

Liège - LégiaPark

29.09 - 01.10

Medical Devices
Pharma & Biotech

TOPRA annual Symposium

Berlin, Germany

October

07.10 - 08.10

Medical Devices

World Drug Safety Congress

Amsterdam, The Netherlands

07.10 - 10.10

Pharma & Biotech
Medical Devices

RAPS US Convergence

Pittsburgh, UK

16.10 - 16.10

Medical Devices

Healixia Clinical Conference

Brussels, Belgium

19.10 - 20.10

In Vitro Diagnostics

Annual EU In Vitro Diagnostics Clinical & Regulatory Conference (Q1)

Brussels, Belgium

23.10 - 23.10

In Vitro Diagnostics
Medical Devices
Pharma & Biotech

QbD Group x Gevers Roadshow: Liège

Diepenbeek - BioVille

23.10 - 24.10

Medical Devices

Team-PRRC Annual Summit

Rome, Italy

25.10 - 28.10

Medical Devices

TCT 2025

San Francisco (CA), USA

28.10 - 30.10

Pharma & Biotech
Medical Devices

CPHI Europe

Frankfurt, Germany

November

17.11 - 20.11

Pharma & Biotech
Medical Devices

Medica

Dusseldorf, Germany

December

11.12 - 11.12

Medical Devices
Pharma & Biotech

Dutch Life Science conference

Leiden, The Netherlands
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