The Boutique Medtech Partner
AMNT is your medical device consulting partner working with innovators from startups to global manufacturers. We specialize in navigating the complex intersections of regulatory strategy, clinical affairs, and quality systems to accelerate compliant market access.
Our team of former FDA reviewers and industry experts is dedicated to your device roadmap. We craft customized strategies for FDA submissions and EU MDR compliance, bridging the gap between clinical innovation and global access to ensure life-saving technologies reach patients safely.
The AMTN Advantage
Our boutique firm delivers specialized expertise in medical device consulting, providing the regulatory, clinical, and quality frameworks necessary to navigate the complex medtech landscape and achieve global market success for devices Class I through III.
Regulatory Strategy
Verification & Validation
Strategy
Quality Foundations
Market Access
Robust Clinical Evaluation & Performance
Strategic FDA & EU MDR Submissions
ISO 13485 & QMS Deployment Excellence
Commercial Medtech Go-To-Market Strategy
Services
Explore our end-to-end expertise for medical device, nutraceutical and pharmaceutical innovators, from early-stage regulatory strategy to global market access and patient adoption.
QMS Development and Support
Develop and implement quality management systems aligned with FDA and ISO 13485 requirements. Build scalable, audit-ready processes and documentation to support compliance from early development through commercialization.
Design Control Support / Development
Establish and maintain design control processes that align with FDA and ISO 13485 expectations. Support the full product lifecycle, including design planning, inputs/outputs, risk integration, and design verification and validation.
Risk Management
Develop and implement risk management frameworks in accordance with ISO 14971. Identify, evaluate, and mitigate risks throughout the product lifecycle to ensure safety, compliance, and effective decision-making.
QMS Audits and Readiness Planning
Evaluate and strengthen your quality management system to ensure alignment with regulatory expectations and industry standards. Identify gaps early, streamline documentation, and prepare confidently for internal and external audits.
Manufacturing & Supply Chain
Support scalable, compliant manufacturing and supply chain strategies from early development through commercialization. Optimize supplier selection, process controls, and risk management to ensure product quality and continuity.
Verification & Validation Testing
Develop and execute verification and validation strategies that demonstrate your product meets design inputs and intended use. Ensure testing is thorough, compliant, and aligned with regulatory expectations to support successful submissions.
Regulatory Submissions
Guide the preparation and submission of regulatory filings, including FDA and global market pathways. Ensure documentation is clear, complete, and strategically positioned to reduce review cycles and accelerate approval.
Patent & IP Support
Provide technical and strategic support for intellectual property development, including prior art review, claim alignment, and documentation. Help ensure innovations are clearly defined and positioned to support strong patent filings.
Product Development / R&D Support
Support end-to-end product development, from early concept through prototyping and design refinement. Provide guidance on R&D strategy, verification and validation planning, and design decisions to accelerate development while maintaining compliance.
Rapid
Prototyping
Accelerate product development with our in-house 3D printing for fast, functional prototypes using materials such as ABS. Leverage an established network of partners for high-quality, production-grade components, including durable plastics like nylon and metal 3D printing, to support iterative design and early validation.
Marketing Material Development / Review
Develop and refine marketing materials that clearly communicate product value while aligning with regulatory expectations. Ensure claims, visuals, and messaging are accurate, compliant, and effectively positioned for target audiences across clinical and commercial settings.
Tradeshow Booth & Model Development
Design and develop impactful tradeshow booths and custom anatomical or product models to effectively showcase your technology. Combine strategic messaging with high-quality physical assets to create engaging, accurate representations that resonate with clinical and commercial audiences.
Industries
AMNT offers a wide range of professional services tailored to meet the unique needs of businesses. From strategic planning and market analysis to R&D and manufacturing, we provide expert guidance and solutions to help your business thrive and grow.
Medical Device
Nutraceuticals
Pharmaceuticals
Consumer Products
Nonprofit MedTech Support Initiative
AMTN is proud to offer pro bono advisory support to nonprofit organizations working with medical devices, diagnostics, and health technologies, with a focus on ensuring products are positioned, communicated, and deployed in alignment with regulatory expectations. Our support is best suited for organizations developing, distributing, or scaling medical technologies that need guidance on regulatory pathways (e.g., FDA or CE mark considerations), compliant marketing claims, support in scaling operations for maximum reach, early-stage R&D strategy, prototyping, verification and validation planning, QMS review and audit readiness. This is structured as a small, focused engagement each month, designed to provide high-value direction rather than ongoing execution, with the option for additional support at a reduced nonprofit rate if more in-depth work is needed.
Medtech Success Stories
“The firm's deep expertise in EU MDR and FDA regulatory pathways was instrumental in our latest 510(k) clearance. They are true partners in navigating the complex medtech landscape.”
David Lee, VP of Regulatory Affairs, CardioTech
“Implementing a global ISO 13485 Quality Management System seemed daunting until we partnered with this firm. Their hands-on approach ensured compliance without slowing our development.”
Jane Smith, CEO, NeuroPulse Innovations
“Their clinical strategy and trial management support were indispensable for our CE Marking. They translated complex demands into an actionable roadmap, ensuring our access timeline was met.”
Maria Garcia, Director of Clinical Affairs, BioSentry
“Their understanding of SaMD regulations helped us launch our digital health platform with full confidence. From classification to market access, the support was flawlessly executed.”
Sophia Patel, Founder, Digital MedSystems
Accelerate Your Product Roadmap Today
