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What We Do Advisory Services Regulatory Strategy & Submissions FDA Guidance

FDA Guidance

Your MedTech Champion for Successful US Market Entry

Navigating FDA pathways is more than a regulatory exercise; it demands a partner who understands how your technology works in the body and how to frame its value to regulators. Avania brings integrated clinical, engineering, and regulatory depth to build submission strategies that anticipate FDA expectations and keep development on track.

With 450+ MedTech clients and 150+ cleared or approved products, we guide innovators through every stage, from concept to clinical validation to market authorization. Backed by specialists in emerging programs such as PCCP, Breakthrough, SaMD/AI/ML, and additive manufacturing, we help teams move faster and with fewer surprises.

Key Differentiators:

  • 450+ customers have worked with us to develop regulatory and market access strategy
  • FDA bioengineering expertise: we speak your product’s technical language
  • Senior leaders from top-10 MedTech companies and emerging MedTech who’ve launched successful products
  • AI/SaMD Center of Excellence for emerging technology pathways
  • Strategic regulatory partners, not just submission preparation
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Understanding the FDA Challenge

FDA reviews hinge on how well your evidence, engineering, and clinical plan align. Gaps in predicate strategy, nonclinical packages, software documentation, or human-factors justification can delay decisions and disrupt timelines. High-risk implantables, novel digital technologies, and AI-enabled devices intensify these demands as FDA guidance continues to evolve.

Avania embeds regulatory architecture early, helping sponsors create defensible submissions that withstand scrutiny and support long-term success.

End-to-End FDA Strategy

Your regulatory pathway must reflect real engineering constraints, clinical design, and future market access requirements. Avania integrates these elements into a cohesive strategy, whether you need early pathway assessment, meeting support, submission development, or deficiency responses.

Partner with Strategy Leaders in MedTech

Our team includes former FDA bioengineering reviewers and senior product leaders from top MedTech companies. This blend of regulatory science and real-world product development ensures your strategy mirrors how successful devices actually reach market approval.

Why Avania: The Trusted Champion for MedTech FDA Guidance

Our Experts

The Minds Behind Your Success

Your FDA program is supported by specialists with deep backgrounds across device classes, diagnostic platforms, combination products, and digital health innovation. Our team includes former FDA reviewers, ex–top 10 MedTech leaders, engineering veterans, and regulatory strategists.

Acacia Parks

VP Regulatory Compliance and Engineering

Acacia Parks, PhD, MBA, RAC

  • 22+ years in neurology, cardiovascular, and combination products
  • Expert in SaMD/AI, digital therapeutics, and wearables
  • Former CSO at Happify, Found, and Unmind with multiple successful SaMD exits
Samuel Engelman

Director, Regulatory

Samuel Engelman

  • 15+ years across cardiovascular, neurology, radiology, urology, and respiratory devices
  • Specialized in mobile/wearables, SaMD/AI, electrical safety, EMC, and wireless coexistence
  • Former regulatory leader at Cook Medical, Eli Lilly, and multiple consulting organizations
Charu Ramkumar

Director, Regulatory

Charu Ramkumar, PhD, MBBS

  • 20+ years in cardiovascular, oncology, and women’s health
  • Expertise in IVD and biocompatibility
  • Doctorate degree in general surgery
  • Prior experience at UMass and Oncostem
Sophia Farcas

Advisory Strategy & Operations Lead

Sophia Farcas, MEng

  • 20+ years of regulatory and scientific leadership experience
  • Doctorate Degree in Psychology
  • Specialized expert in Software as a Medical Device (SaMD), Digital Therapeutics (DTx), wearables
  • Involved in scientific and regulatory strategy for 50+ software and algorithm/AI devices
  • End-to-end-solutions expert focused on designing integrated regulatory and advising solutions across your program lifecycle.
Subo Perampalam

Senior Regulatory Consultant

Subo Perampalam, PhD Medical Biophysics

  • 20+ years in oncology, cardiology, and pulmonary/respiratory devices
  • IVD/IVDR specialist with EUA and humanitarian device expertise
  • Former Product Leader at SQI Diagnostics and Head of Diagnostics at Nicoya
Pooja Upadhyay

Principal Regulatory Consultant

Pooja Upadhyay, MS

  • 17+ years across neuromodulation, cardiology, MSK, and diabetes/endocrine
  • Expert in combination products, Class III implants, and SaMD/DTx
  • Prior experience at Harvard, Fresenius, and CeQur developing first-in-class insulin delivery systems
Nidhi Vaishnav

Senior Regulatory Consultant

Nidhi Vaishnav, MSc

  • 17+ years spanning neuromodulation, radiology, oncology, and women’s health.
  • Specialized in imaging devices, SaMD/AI/DTx, and drug delivery.
  • ISO 13485/TPECS Lead Auditor.
  • Prior roles at Perimeter AI and Biocon.

Comprehensive FDA Capabilities

Strategic assessments for device, diagnostic, and digital health innovators, including:

  • Pathway and predicate strategy
  • Competitive and regulatory landscape review
  • Evidence requirements
  • Risk assessment and mitigation planning

End-to-end support for Q-Subs, informational meetings, and parallel scientific advice. For combination products, we align strategy across review divisions through targeted Type B and C interactions.

Experience securing Breakthrough Designation and advancing devices through expedited programs including Fast Track, RMAT, TAP, and STeP.

Full submission development for 510(k), De Novo, PMA, and hybrid or combination pathways. With 60+ De Novo projects, Avania is a recognized leader in supporting novel technologies without predicates.

Direct experience with FDA innovation offices, including:

  • Digital Health Center of Excellence (SaMD, AI/ML, cybersecurity)
  • Additive Manufacturing Program (100+ cleared devices)
  • OSEL collaboration for novel technology evaluation

Expertise across drug–device, biologic–device, and integrated systems. We build early RFD strategies and manage intercenter coordination to reduce ambiguity and avoid downstream delays.

Deep specialization in diagnostic instruments, wearables, and monitoring technologies. We partner effectively with pharma teams for coordinated CDx submissions and ensure diagnostic-device alignment across regulatory expectations.

Hands-on support for DHF development, risk assessments, ISO 13485/MDSAP foundations, and integrated quality system solutions.

Regulatory strategy for DTx, SaMD, and AI/ML products backed by cybersecurity expertise and technical depth in algorithm validation, GMLP compliance, and PCCP readiness.

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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 FDA Interactions

Strategic and Collaborative Partnership:

Avania operates as a true extension of your team. Our FDA specialists work side-by-side with your engineering, clinical, and quality groups to shape strategies rooted in how your device is designed, how it performs, and how FDA will evaluate it. We provide direct, honest guidance that protects your investment and keeps your timeline moving.

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Proven, Purpose-Built Expertise:

Our advisory team brings together former FDA bioengineering reviewers, senior product leaders from top MedTech companies, and specialists across emerging technologies such as AI/ML, digital therapeutics, and cybersecurity. This is purpose-built regulatory expertise informed by how successful devices are engineered, validated, and approved.

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Flexible Engagement:

Engage Avania for early pathway assessment, embed our experts within your team for hands-on submission development, or rely on us for full FDA and EU MDR program management. Our model adapts to the needs of both first-time submitters and established manufacturers advancing complex PMA, De Novo, or hybrid programs.

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Quality and Compliance:

All Avania programs operate under device-specific quality systems aligned with FDA 21 CFR Part 820, ISO 13485, and ISO 14155. Our processes are purpose-built for medical devices and diagnostics, ensuring disciplined execution and consistently high-quality deliverables.

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Ready to Navigate FDA Expectations with

Confidence?

Work with Avania’s regulatory experts to interpret current guidance, evaluate risks in your submission package, and shape a strategy that supports approval without avoidable delays.

Tell Us About Your Project