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What We Do Advisory Services Regulatory Strategy & Submissions IVD/IVDR Guidance

IVD/IVDR Guidance

Your MedTech Champion for Diagnostic Innovation

The definition of an IVD is expanding. Wearable biosensors, point-of-care analyzers, AI-driven diagnostic software, and connected monitoring platforms now sit alongside traditional assay systems. At the same time, EU IVDR has introduced the most significant regulatory shift diagnostics have faced in decades.

Avania brings a MedTech-first perspective to this evolving space. Our heritage is medical devices and diagnostic instruments, not reagent-only workflows. We understand hardware–software integration, sensor technologies, usability engineering, and the full design architecture surrounding modern diagnostics. When your innovation blends analytical performance with engineered systems, our multidisciplinary depth becomes your competitive advantage.

Key Differentiators:

  • Diagnostic instrument and device-engineering expertise not found in reagent-focused consultancies
  • Toronto Global Design Lab supporting hardware, firmware, and usability engineering
  • Direct IVDR transition experience, including QMS alignment and notified body coordination
  • CDx strategy rooted in MedTech specialization, ensuring seamless alignment with pharma partners
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Your Compass to IVD Success

Analytical and clinical performance are only part of the equation. Devices, wearables, and connected platforms also require hardware verification, software validation, usability engineering, electrical safety, and cybersecurity justification. Most IVD consultancies grew from assay development; Avania integrates IVD regulatory strategy with device engineering, software validation, and clinical execution, accelerating your path to market.

Under IVDR, notified body involvement increases rigor across every class of diagnostic device. Without strategic planning, certification can extend timelines and create unnecessary evidence burdens. Avania brings engineering, regulatory, and clinical expertise together in a single program: performance evaluation aligned with design controls, clinical evidence coordinated with hardware testing, and technical documentation built to withstand review. One partner who understands the complete system driving your diagnostic.

Integrated End-to-End IVD Expertise

IVD development touches design controls, clinical evidence, software validation, quality systems, and market access. Avania integrates these disciplines so you’re not managing multiple vendors working from different assumptions.

Our Global Design Lab supports hardware and firmware development; our SaMD team addresses diagnostic software; our clinical operations group executes performance studies. Engage us at any point and gain guidance informed by what comes next.

MedTech Focus, Unparalleled IVD Success

Traditional IVD consultancies focus on reagents and laboratory workflows. Avania adds what they lack: deep expertise in diagnostic instruments, wearables, and connected platforms. We understand sensor physics, firmware architecture, signal processing, and user-interface design, alongside analytical validation and performance evaluation.

For CDx programs, this becomes a strategic advantage. While pharma partners drive therapeutic development, Avania ensures the device side stays aligned, bridging regulatory frameworks that CDx-only consultancies often view from a single direction.

Why Avania: The Trusted Champion for IVD/IVDR Guidance

Our Experts

The Minds Behind Your Success

Our IVD specialists bring deep regulatory, engineering, and clinical expertise across the full diagnostic lifecycle. Each advisor combines hands-on product development experience with category-specific regulatory insight.

Subo Perampalam

Senior Regulatory Consultant & IVD Practice Lead

Subo Perampalam, PhD Medical Biophysics

  • 20+ years across diagnostic development, regulatory strategy, and commercial leadership
  • Experience includes leading IVD platform development (SQI Diagnostics) and overseeing diagnostic instrument commercialization (Nicoya)
  • Expertise: IVD/IVDR strategy, performance evaluation, EUA and humanitarian devices, diagnostic instrument development, oncology and cardiology diagnostics
Charu Ramkumar

Director, Regulatory

Charu Ramkumar, PhD, MBBS

  • 20+ years across cardiovascular, oncology, and women’s health diagnostics
  • Medical training combined with regulatory experience informs clinical evidence requirements and performance evaluation strategy
  • Expertise: IVD regulatory strategy, biocompatibility, cardiovascular and oncology diagnostics
Samuel Engelman

Director, Regulatory

Samuel Engelman

  • 15+ years across cardiovascular, neurology, radiology, urology, and respiratory devices
  • Specializes in wearables, SaMD/AI diagnostics, and connected platforms
  • Expertise: Wearable diagnostics, SaMD/AI, connected devices, EMC and wireless coexistence
Acacia Parks

VP Regulatory Compliance and Engineering

Acacia Parks, PhD, MBA, RAC

  • 22+ years in neurology, cardiovascular, and combination products
  • Deep expertise in SaMD, AI, and digital diagnostics
  • Expertise: Digital diagnostics, SaMD/AI strategy, DTx, wearables, combination products

Comprehensive IVD & IVDR Capabilities

QMS alignment with Article 10(8), notified body strategy, performance evaluation reports aligned with Annex XIII, clinical evidence planning, and technical documentation remediation. Guidance across written agreements and ongoing lifecycle obligations.

Analytical, clinical, and scientific validity planning supported by risk-proportionate strategies. For novel diagnostics, Annex XIV clinical performance study design and execution. Evidence packages built to satisfy notified body expectations without inflating timelines.

For analyzers, wearables, or platform-based IVDs, regulatory strategy must reflect engineering reality. Hardware and firmware development, IEC electrical safety testing, connected-device considerations, and human-factors engineering are all supported by our Toronto Global Design Lab.

Software requirements under IVDR intersect with the EU AI Act and evolving algorithm-governance expectations. We structure defensible documentation, validation plans, and change-control strategies that support both current compliance and future adaptability.

CDx programs require alignment across two regulatory systems. Avania ensures the diagnostic device side progresses reliably while pharma partners drive therapeutic development, coordinating evidence, timelines, and regulatory interactions across both frameworks.

Support for FDA 510(k), De Novo, PMA, and global registrations across Canada, Australia, Japan, and emerging markets. Core dossiers leveraged efficiently while adapting to region-specific requirements for diagnostics and integrated platforms.

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Client Success & Impact:

Proof of Our Partnership

“Avania strikes the right balance of speed and rigor. Highly recommend them for early-stage MedTech teams navigating complex regulatory paths. Exceptionally collaborative and pragmatic. Avania brought senior, device-savvy guidance, anticipated FDA’s perspective, and felt like an extension of our team. Responsive, clear, and kind.”

Ashley King, Chief Commercial Officer
Turing Medical

“Avania delivered exceptional technical work while seamlessly managing the entire process. The results speak for themselves. Avania’s technical excellence and project management were critical to bringing our vision to life.”

Matthew MacKenzie, President
MacKenzie Healthcare Technologies

our approach

Avania’s Integrated Approach to IVD Excellence

Strategic Partnership:

We operate as an extension of your team, providing direct access to senior specialists, clear communication, and aligned decision-making. Challenges are surfaced early, addressed collaboratively, and managed with shared accountability.

Hospital medical group meeting team

Purpose-Built Expertise:

Our IVD regulatory experts, device engineers, software specialists, and clinical operations teams work as one unit. Your regulatory strategy reflects how your diagnostic is built, how it performs, and how it will be evaluated — not siloed interpretations from separate consultancies.

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Flexible Engagement:

Engage us for full IVDR transition, targeted documentation support, CDx strategy, or performance-study execution. Our model scales from turnkey programs to embedded team augmentation.

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Operational Excellence:

Our quality systems are engineered for medical devices and diagnostics, aligned with ISO 14155, FDA 21 CFR Part 820, MDR, and IVDR expectations. When we execute studies or prepare submissions, compliance is built into every step.

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Ready to Strengthen Your IVD Regulatory

Strategy?

Engage with Avania’s IVDR and diagnostic specialists to clarify requirements, assess evidence needs, and build a compliant path from analytical validation to market access.

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