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What We Do Advisory Services Regulatory Strategy & Submissions EU MDR Strategy & CE Marking Excellence

EU MDR Strategy & CE Marking Excellence

Your MedTech Champion for Navigating MDR with Confidence and Control

The European medical device landscape has fundamentally changed. EU MDR (2017/745) introduced the most significant regulatory shift the industry has faced in decades, raising expectations for clinical evidence, technical documentation rigor, and post-market oversight while creating sustained notified body capacity constraints.

Avania brings a different perspective to MDR. Our heritage is medical device engineering and product development, not documentation alone. We understand design controls, risk management, biocompatibility, software validation, and manufacturing realities in ways traditional regulatory consultancies do not. When your CE marking strategy demands technical documentation that accurately reflects how your device was designed, built, and validated, our engineering-first approach becomes a strategic advantage.

Key Differentiators:

  • MDR compliance grounded in device engineering, not template-driven documentation
  • Proven MDD-to-MDR transition experience across 200+ devices and therapeutic areas
  • Global regulatory alignment leveraging MDR technical documentation for FDA, Health Canada, and international submissions
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Your Compass to CE Mark Success

MDR compliance requires clinical evidence, GSPR alignment, post-market surveillance, and notified body readiness. For devices involving novel technologies, software components, or complex risk profiles, it also demands design history files that withstand technical scrutiny, clinical evaluation reports built on defensible equivalence analysis, and PMCF strategies proportionate to real-world risk.

Most MDR consultancies approach compliance as a documentation exercise. Avania operates as an integrated clinical and product development partner. Our engineering and regulatory teams work together so your CER reflects genuine design rationale, your PMCF plan aligns with your risk management file, and your technical documentation tells a coherent, defensible story.

In today’s constrained notified body environment, audit readiness is not optional. Avania combines MDR regulatory depth with device engineering capability: technical file development alongside verification strategy, clinical evidence planning alongside human factors validation. One partner who understands both regulation and engineering reality, reducing findings and accelerating certification.

Integrated End-to-End IVD Expertise

MDR compliance touches every part of your organization: design controls, clinical evidence, software lifecycle, post-market surveillance, and market access. Avania integrates these disciplines so you are not coordinating multiple vendors with conflicting assumptions.

Our Global Design Lab supports hardware verification and usability. Our SaMD team addresses software lifecycle and cybersecurity requirements. Our clinical operations team executes PMCF studies. Engage us at any point and receive guidance informed by what follows.

Engineering Depth, Unparalleled MDR Success

Most regulatory consultancies are built around compliance administration. Avania adds what they lack: deep engineering and product development expertise.

We understand design controls, risk management, manufacturing validation, and clinical evidence in parallel with GSPR mapping and Annex requirements. When notified bodies challenge design rationale or equivalence justification, we respond with technical credibility, because we helped build the device, not just document it.

For complex devices, borderline products, combination products, active implantables, and AI-enabled technologies, this engineering depth becomes decisive.

Why Avania: The Trusted Champion for EU MDR Strategy & CE Marking Excellence

Our Experts

The Minds Behind Your Success

Your MDR and CE marking strategy is guided by leaders with deep regulatory, engineering, and clinical documentation expertise.

Nidhi Vaishnav

Senior Regulatory Consultant | EU MDR & CE Mark Practice Lead

Nidhi Vaishnav, MSc

  • 17+ years guiding global and EU MDR compliance
  • ISO 13485 and TPECS Lead Auditor
  • Extensive notified body experience across complex device categories including SaMD and combination products
  • Expertise: MDR strategy, GSPR mapping, CER oversight, PMCF planning, audit readiness
Anne Leijsen

Director, Medical Writing | EU MDR Clinical Evaluation Lead

Anne Leijsen, MSc

  • Leads Avania’s European medical writing team from the Netherlands.
  • Specializes in CERs aligned with Annex XIV and MEDDEV 2.7/1 Rev 4, with deep expertise in equivalence and PMCF integration.
  • Expertise: CER development, PMCF strategy, MDR clinical documentation, medical writing governance
Charu Ramkumar

Director, Regulatory

Charu Ramkumar, PhD, MBBS

  • 20+ years across cardiovascular, oncology, and women’s health, bringing clinical insight to MDR evidence planning and global regulatory strategy.
  • Expertise: MDR/IVDR strategy, biocompatibility, clinical evidence planning
  • Doctorate degree in general surgery

Comprehensive EU MDR & CE Marking Capabilities

Legacy device remediation, Annex II/III gap analysis, and strategic prioritization when resources are constrained. Experience transitioning 200+ products across therapeutic areas — from focused updates to complete evidence rebuilds — without unnecessary scope expansion.

GSPR mapping, design dossier development, and technical file architecture that reflects engineering reality. Risk management aligned with ISO 14971:2019, MDR-ready biocompatibility documentation, and manufacturing validation packages built for notified body review.

CERs grounded in systematic literature review and defensible equivalence analysis. PMCF strategies proportionate to risk and intended use. Clinical investigation planning and execution where required, from protocol development through CIP approval and study delivery.

MDR software requirements intersecting with the EU AI Act create complex regulatory pathways. We structure documentation, lifecycle controls, and change-management strategies that meet current Annex I requirements while positioning for regulatory evolution, including PCCPs and cybersecurity alignment with MDCG guidance.

Strategic notified body selection based on therapeutic expertise and capacity. Pre-submission engagement, audit preparation, and finding-response strategies. QMS alignment with Article 10 requirements and sustainable compliance infrastructure.

FDA 510(k), De Novo, and PMA pathways leveraging MDR technical documentation. Health Canada, TGA, and emerging market submissions built from a single core dossier—turning MDR investment into global acceleration, not parallel workstreams.

our approach

Avania’s Integrated Approach to MDR Excellence

Strategic Partnership:

We operate as an extension of your team, not a document vendor. That means direct access to senior experts, transparent communication when challenges arise, and shared accountability for CE certification outcomes.

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Purpose-Built Expertise:

Our teams combine MDR regulatory specialists with device engineers, clinical operations leaders, and quality systems experts. Your regulatory strategy reflects how your device is actually designed, manufactured, and clinically evaluated.

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Flexible Engagement:

Engage Avania for complete MDD-to-MDR transition programs or targeted remediation. Expand from CER development to PMCF execution. Gap assessments, embedded team support, or turnkey certification programs, all scaled to your timeline.

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Operational Excellence & Quality Assurance:

Our quality systems are built specifically for medical devices, aligned with ISO 13485, ISO 14971, MDR Annex requirements, and harmonized standards. Compliance infrastructure is in place before work begins, reducing burden and review friction.

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Ready to Move Your Device Through MDR with

Confidence?

Advance your CE marking strategy with a partner built for MedTech. Avania integrates engineering insight, regulatory expertise, and clinical execution to help you achieve and maintain MDR certification with clarity and control.

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