QbD Group

QbD Group is a European regulatory, clinical and quality partner supporting medical device and in vitro diagnostic (IVD) manufacturers with EU MDR and IVDR compliance, from early EU feasibility and gap assessment through CE marking, Notified Body engagement, and long-term post-market surveillance (PMS) and PMCF. QbD integrates regulatory strategy, clinical evidence and performance evaluation, ISO 13485 quality management systems, and EU Authorized Representative services to help companies achieve structured, Notified Body–ready submissions and sustainable European market access. With dedicated expertise in SaMD (software as a medical device), AI-enabled medical devices, and digital health compliance, QbD helps reduce regulatory uncertainty and accelerate predictable EU entry.

Landing in Europe (LiE) – MedTech: EU Market Entry Under MDR and IVDR

QbD’s Landing in Europe (LiE) – MedTech service provides a structured pathway to enter and commercialise medical devices in the EU under MDR and IVDR. The work typically begins with EU feasibility and a targeted gap assessment to confirm device classification, conformity assessment route, and the evidence expected for CE marking. By mapping requirements early, QbD helps manufacturers avoid late-stage surprises and align product plans with EU regulatory expectations.

LiE – MedTech also supports the coordination required to move from strategy to execution, including the sequencing of regulatory, clinical, and quality deliverables. QbD guides manufacturers through CE marking planning and the practical steps needed to prepare for Notified Body review. This creates a clearer route to EU market access and supports commercial timelines with realistic regulatory milestones.

Notified Body Engagement and Notified Body–Ready Submissions

QbD helps manufacturers build Notified Body–ready submissions by combining early gap analysis with a structured technical documentation strategy. This includes ensuring the technical file or design dossier is coherent, traceable, and aligned with MDR or IVDR requirements, reducing the risk of extensive rounds of questions. QbD also supports manufacturers in preparing for Notified Body interactions by clarifying evidence expectations and aligning internal stakeholders around submission content.

For companies navigating MDR transition or IVDR transition, Notified Body engagement often becomes the critical path. QbD supports structured execution so that regulatory, clinical, and ISO 13485 quality system elements reinforce one another rather than creating conflicting outputs. The result is a more efficient review process and stronger readiness for assessment outcomes.

MDR Transition, IVDR Transition and Lifecycle Compliance

QbD provides end-to-end MDR and IVDR lifecycle support, helping manufacturers maintain compliance beyond initial certification. For MDR transition, QbD supports the planning and upgrading of documentation, evidence and processes needed to maintain CE certificates and avoid disruptions to EU supply. For IVDR transition, QbD supports the increased emphasis on performance evidence and ensures the technical documentation is built to meet current scrutiny levels.

Lifecycle compliance also includes setting up the processes needed to sustain market access, including vigilance interfaces and change management that protect certification status. QbD’s approach is designed to reduce costly rework by ensuring that each deliverable fits into the broader compliance system. This structured, lifecycle view is particularly valuable for manufacturers with evolving product portfolios.

Clinical Evidence Development and IVDR Performance Evaluation

QbD supports clinical evidence development for medical devices and performance evaluation activities for IVDs, aligning evidence plans with intended purpose, claims, risk management and regulatory pathway. For MDR, QbD helps manufacturers plan and compile clinical evaluation inputs that support safety and performance and stand up to Notified Body scrutiny. For IVDR, QbD supports performance studies and the documentation needed to demonstrate analytical and clinical performance.

By integrating regulatory strategy with clinical and performance planning, QbD helps teams create evidence packages that are proportionate and defensible. This reduces uncertainty during assessment and supports consistent decision-making when products change or new indications are added. Evidence development is treated as a core part of CE marking readiness, not a last-minute task.

ISO 13485 Quality Management Systems for Medical Devices and IVDs

QbD designs and implements ISO 13485 quality management systems that support both day-to-day operational control and MDR/IVDR deliverables. Rather than creating generic procedures, QbD aligns ISO 13485 processes with practical needs such as design controls, supplier qualification, risk management interfaces, CAPA, and document control. This makes the QMS more usable for teams while remaining robust for audits and certification.

For startups and scale-ups, QbD provides scalable ISO 13485 QMS implementation that fits the organisation’s stage, enabling growth without rebuilding the system later. For established manufacturers, QbD helps strengthen or remediate existing QMS elements to support CE marking, surveillance audits and post-market obligations. The aim is a quality system that supports sustainable compliance in Europe.

SaMD / Medical Device Software and AI-Enabled Digital Health Compliance

QbD provides regulatory and quality support for SaMD (medical device software) and AI-enabled solutions, where EU expectations span clinical evaluation, software lifecycle controls and ongoing performance management. QbD supports MDR compliance for software products by aligning documentation with intended use, validation approaches and usability engineering. QbD also addresses common software-specific requirements such as cybersecurity, software verification and validation evidence, and managing updates in a controlled way.

For AI-based devices and digital health products, QbD helps manufacturers navigate evolving EU requirements that can affect both claims and compliance evidence. By connecting regulatory strategy with practical engineering and quality deliverables, QbD supports a smoother path to CE marking and long-term market access. This is particularly important for products that iterate frequently or rely on complex data-driven performance.

EU Authorized Representative and Support for Non‑EU Manufacturers

QbD provides EU Authorized Representative support and market access assistance for non‑EU manufacturers placing medical devices or IVDs on the European market. This helps manufacturers meet regulatory obligations while maintaining clear, compliant communication channels for documentation and post-market responsibilities. When combined with QbD’s regulatory, clinical and ISO 13485 expertise, Authorized Representative support becomes part of a coordinated compliance model rather than a standalone service.

This integrated approach is useful for manufacturers managing EU entry alongside other global regulatory priorities. QbD’s teams help keep technical documentation and compliance activities aligned, supporting predictable EU operations over the long term. The result is reduced fragmentation and clearer accountability across the EU compliance landscape.

Flagship Case Studies: MDR and IVDR Compliance in Practice

QbD supported Lifestream Pharma with CE Mark Renewal under MDR, delivering a successful MDR transition and CE mark renewal while maintaining regulatory continuity and structured Notified Body engagement. This case demonstrates QbD’s ability to coordinate technical documentation strategy, readiness planning and submission execution to support uninterrupted EU market access. Case study link: CE Mark Renewal under MDR – Lifestream Pharma (Medical Device).

QbD also supported The LVOne Device on its Journey Toward IVDR Compliance, providing comprehensive IVDR support including regulatory strategy, performance evaluation and structured technical documentation development. By guiding the manufacturer through IVDR transition complexity and preparing for Notified Body assessment, QbD helped build a sustainable compliance pathway for continued EU access. Case study link: Journey Toward IVDR Compliance – The LVOne Device.

Company Background

QbD Group works with startups, scale-ups and established manufacturers to translate innovation into compliant, market-ready medical devices and IVDs, acting as a single partner across the full device lifecycle to ensure structured execution and sustainable compliance in Europe.

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