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What We Do Advisory Services Regulatory Strategy & Submissions

Regulatory Strategy & Submissions

Your MedTech Champion for Regulatory Strategy & Submissions Success

MedTech research and development is complex and highly regulated. When you need to navigate regulatory requirements, determine optimal submission strategies, and ensure compliance across global markets, you need a partner with deep regulatory expertise, practical product leadership experience, and a record of proven success. Avania delivers comprehensive regulatory strategy and submissions support that accelerates your path to market.

Key Differentiators:

  • 25+ years of Regulatory Success across FDA, EU MDR/IVDR, and global markets
  • 200+ Regulatory Approvals/Clearances of in medical devices and combo products
  • Regulatory Center of Excellence for SaMD/AI, robotics, wearables and next gen tech
  • Integrated Regulatory Expertise across all therapeutic areas and device types
  • Field-tested Executives with real world product experience in MedTech
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Engineers Building and Developing a Prosthetic Artificial Intelligence

Navigating Regulatory Complexity with Confidence

Understanding Your Challenges

The global regulatory landscape is evolving rapidly, and for MedTech innovators, the path to approval can be as complex as the innovation itself. Companies face:

  • Diverse and ever-changing global requirements across FDA, EU MDR/IVDR, and beyond
  • Resource constraints and funding pressures during evidence and documentation development
  • Time-to-market urgency demanding precision and strategic planning
  • High stakes for errors that could lead to costly remediation or delayed market access

What’s at Stake

Regulatory missteps can mean more than delays; they can define success or failure. With growing competition and increasing scrutiny from global authorities, the right partner is essential for achieving approval efficiently and maintaining compliance through commercialization.

Why Avania: The Trusted Champion for MedTech Regulatory Success

Our Experts

The Minds Behind Your Success

Speak with our Experts
sam engelman

Director, Regulatory

Sam Engelman

  • 15+ years of Global Regulatory program leadership, and prior regulatory leader at Cook Medical
  • Global strategist for FDA and experience with China NMPA CMDE medical devices center
  • ISO 13485 and Cybersecurity expertise
  • Specialized expertise in electrically active devices
Acacia Parks

VP Regulatory Compliance and Engineering

Acacia Parks, PhD, MBA, RAC

  • 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
  • Thought leader in next generation software medical devices, imaging, and neuromodulation
Charu Ramkumar

Director, Regulatory

Charu Ramkumar, PhD, MBBS

  • 20+ years of global healthcare experience
  • Expert in oncology and cancer biology and cardiovascular diseases
  • Doctorate degree in general surgery
  • Specialized expert in implantable and minimally invasive surgical devices

Our Experts

The Minds Behind Your Success

Speak with our Experts
Subo Perampalam

Senior Regulatory Consultant

Subo Perampalam, PhD Medical Biophysics

  • 20+ years of Global Regulatory program leadership for FDA and Health Canada
  • Expert in pulmonary, respiratory, and infectious disease
  • Led multiple Emergency Use Authorizations (EUAs) and Humanitarian Device programs
  • Specialized expertise in IVD diagnostics and EU IVDR CE marking
Sophia Farcas

Advisory Strategy & Operations Lead

Sophia Farcas, MEng

  • FDA and global redgulatory and market access expert
  • Specializing in solutions development for enterprise and emerging manufacturers
  • Expertise in CAMEDA – Canadian Medtech Alliance, US SBIR/R-Series Grant support, EU grants and tenders and regulatory support for other public grant and investment projects
  • Liaison for regulatory and compliance due diligence, investment analysis, and functional service provider (FSP) programs
Pooja Upadhyay

Principal Regulatory Consultant

Pooja Upadhyay, MS

  • 17+ years leading FDA and Health Canada implantable and high risk device programs
  • Specialized expertise in neurology and neuromodulation expertise and cardiac devices
  • Deep expertise in drug-delivery systems across modalities and therapeutic areas
  • Expert in MDR and borderline combination products

Our Experts

The Minds Behind Your Success

Speak with our Experts
Nidhi Vaishnav

Senior Regulatory Consultant

Nidhi Vaishnav, MS

  • 17+ years leading FDA and global implantable and wound care programs
  • Specialized expertise in wound care, general surgery, and implantables
  • ISO 13485 and TPEC Lead Auditor
  • Dedicated expert in regulatory compliance for medical devices

Where Engineering Meets Regulatory

We are engineers that know FDA, from prior FDA bioengineering staff to program leaders from companies like GE, Cook, Phillips, Baxter, Danaher (Cytiva & Beckman), and more, our regulatory team is shaped by an engineering first mentality. We live and breathe medical devices and diagnostic technologies, and we know how to engage with clinical and engineering leaders to make your programs seamless.

Our regulatory experts work alongside our world class product development and engineering team at our Toronto Medtech Design Lab, where our Usability and Human Factors (UX/HF) Center of Excellence is located.

Other advisors make a regulatory plan, while we offer integrated solutions to complete your engineering, verification and validations (V/V), and usability and human factors (UX/HF) studies with our expert engineering staff and regulatory experts working hand in hand with focus on ISO 13485, ISO 14971 risk management, and usability engineering (IEC 62366) implementation.

Our regulatory and product development strategies work hand in hand to ensure you are ready for for multi-regional approvals.

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Continuum of Expertise

Market access is a single milestone in the broader MedTech journey. Avania integrates regulatory insights, clinical evidence development, and commercial considerations to build smarter, faster reimbursement strategies from day one. This continuity means you can jump in anywhere in the development process and receive tailored expertise that aligns with your overall product strategy.

MedTech Focus, Purpose-Built

Unlike generalist CROs or pharma-first organizations, Avania was designed primarily for MedTech. Our experts understand the unique clinical, regulatory, and economic nuances of devices, diagnostics, and combination products, ensuring every strategy is tailored to your technology and target markets..

Comprehensive Regulatory Strategy & Submission Capabilities

Strategic Advising Offerings:

  • Determine regulatory strategy for novel products in various jurisdictions
  • Advise on sequencing of regulatory submissions and progressive indications for use
  • Negotiate regulatory pathway, pre-clinical, and clinical testing requirements with regulators
  • Draft and compile regulatory correspondence, including pre-submissions and marketing applications
  • Provide expert and responsive feedback to address regulatory deficiencies
  • Ensure smooth interactions with regulatory bodies across the globe
  • Pre-submission meetings and regulatory pathway determination
  • 510(k), PMA, and De Novo writing, review, and submission strategies
  • Breakthrough Device Designation applications
  • FDA correspondence and deficiency response
  • Post-market surveillance and compliance support
  • EU MDR and IVDR transition planning and compliance
  • CE marking strategies and technical documentation
  • Clinical evaluation and post-market clinical follow-up (PMCF) plans
  • Notified body interactions and conformity assessment procedures
  • Vigilance reporting and post-market surveillance
  • Australian Therapeutic Goods Administration (TGA) regulatory strategy
  • Health Canada regulatory submissions
  • International registration and market entry strategies
  • Multi-jurisdictional regulatory harmonization
  • Clinical evaluation reports and literature reviews
  • Post-market surveillance and clinical follow-up documentation
  • Study design and protocol development
  • Investigator’s brochure and study results reporting
  • Scientific literature and publication support
  • Pre-submission optimization for FDA Elsa, eSTAR, other computerized regulatory review systems
  • AI/ML device documentation formatting for machine-readable FDA review processes and automated assessment tools
  • Regulatory submission de-risking through AI and/or cybersecurity review readiness for 510(k), PMA, de novo, and safety submissions
  • Strategic preparation for evolving FDA AI-enabled review paradigms and next-generation regulatory assessment platforms

Specialized MedTech Regulatory Solutions:

  • Software Bill of Materials (SBOM) development and validation for FDA/NMPA submissions
  • Cybersecurity risk assessments, threat modeling, and attack surface analysis
  • FDA Section 524B compliance documentation and premarket cybersecurity submissions
  • Vulnerability monitoring and management plans for post-market surveillance
  • Penetration testing coordination and security validation documentation
  • Secure Product Development Framework (SPDF) implementation and quality system integration
  • ISO 10993 biological evaluation plans and risk-based testing strategy development
  • Biological safety assessments for patient contact materials and duration categories
  • Chemical characterization and extractables/leachables (E&L) study design
  • Toxicological risk assessments and biocompatibility test report interpretation
  • EU MDR Annex I biological evaluation documentation and technical file support
  • Post-sterilization biocompatibility testing strategy and material characterization studies
  • FDA Breakthrough Device Designation applications and strategic interaction planning, including ther Total Product Life Cycle Advisory Program (TAP)
  • FDA Safer Technologies Program (STeP) eligibility assessments and submissions
  • FDA De Novo pathway strategy for novel device classifications and predicate establishment
  • FDA 510(k) Predetermined Change Control Plans (PCCP) for AI/ML and software devices
  • Post-designation milestone planning, FDA sprint meetings, and accelerated review coordination
  • International innovation pathway assessments and regulatory strategy development
  • Regulatory pathway analysis and optimal route-to-market strategy development
  • Due diligence regulatory assessments for M&A transactions and investment decisions
  • Global regulatory roadmapping with timeline optimization and milestone planning
  • Competitive intelligence analysis and regulatory positioning strategy
  • Market entry sequencing for multi-regional launch strategies (FDA, MDR, PMDA, NMPA)
  • Regulatory risk assessments and mitigation planning for product development portfolios
  • Analysis of marketing claims and software functions for low-risk devices, including those that are 510(k) exempt or enforcement discretion
  • Global labeling harmonization and claims substantiation across FDA, MDR, and PMDA requirements
  • Risk-benefit communication optimization and contraindication/warning development
  • Instructions for Use (IFU) strategic development and usability validation coordination
  • Marketing claims review and regulatory clearance strategy for commercial communications
  • Post-market labeling updates and lifecycle management for evolving clinical evidence
  • EU MDR vigilance system implementation and Periodic Safety Update Report (PSUR) preparation
  • FDA Medical Device Reporting (MDR) adverse event analysis and trend identification
  • Post-Market Clinical Follow-up (PMCF) study design and regulatory submission strategy
  • Global vigilance harmonization and adverse event assessment across multiple jurisdictions
  • Registry development and real-world safety data collection infrastructure
  • Corrective and Preventive Action (CAPA) regulatory communications and field safety notices
  • Real-world evidence (RWE) strategy development and regulatory acceptance planning
  • Clinical evaluation plans and clinical data requirements optimization across global markets
  • Post-market clinical study design and evidence generation roadmapping
  • Registry development and patient-reported outcome (PRO) integration
  • Regulatory science strategy and innovative clinical endpoint development
  • Health technology assessment (HTA) evidence planning and value demonstration frameworks
  • ISO 13485 quality management system implementation and FDA QSR compliance integration
  • Design controls optimization and global regulatory harmonization across manufacturing sites
  • Toronto Design Lab and UX/Human Factors Center of Excellence integration for regulatory submissions
  • Global manufacturing strategy and supply chain regulatory compliance coordination
  • Risk management (ISO 14971) and usability engineering (IEC 62366) implementation
  • Quality system harmonization and technical file preparation for multi-regional submissions
  • FDA Digital Health pre-certification pathway strategy and Software as Medical Device (SaMD) classification optimization
  • Robotic and integrated sensor device regulatory strategy
  • Consumer-grade to medical-grade device transition strategy and regulatory pathway optimization for wearables and robotic assistive technologies
  • Interoperability standards compliance and health information exchange integration for seamless care coordination across monitoring and robotic platforms

Technology Expertise

Our regulatory expertise spans all critical medical device technology segments where specialized expertise drives competitive advantage:

  • Medical Imaging Equipment – Strategic support for advanced imaging technologies, AI-enhanced diagnostic systems, and radiation safety regulatory requirements
  • Emerging Technologies – Agile expertise across breakthrough device categories and next-generation MedTech innovations requiring novel regulatory approaches
  • Active Implantable Devices – Expert guidance for ICDs, pacemakers, neurostimulators, and other active implants requiring extensive post-market surveillance and cybersecurity frameworks
  • Minimally Invasive Surgery Instruments – Regulatory optimization for advanced energy devices, single-use technologies, and robotic-assisted surgical platforms
  • Software as Medical Device (SaMD) & AI/ML – Leading expertise in FDA Digital Health pathways, predetermined change control plans, and algorithmic validation for continuous learning systems
  • Wearables & Remote Patient Monitoring – Strategic guidance for consumer-to-clinical device transitions, RPM reimbursement optimization, and digital biomarker validation
  • Robotics & Surgical Systems – Comprehensive support for robotic surgery platforms, rehabilitation devices, and capital equipment regulatory strategies with extensive clinical evidence requirements
  • Interventional Devices – Deep experience across cardiovascular, neurovascular, and oncology interventional technologies, including complex Class III PMA pathways and specialist training programs
  • In Vitro Diagnostics (IVD) – Specialized in EU IVDR compliance, companion diagnostics, and complex clinical validation strategies for next-generation diagnostic platforms
Doctor using his tablet

Therapeutic Focus

Our regulatory expertise spans all major therapeutic areas where Avania excels:

  • Cardiovascular – Deep expertise across high-risk and complex device programs, including structural heart, vascular, and electrophysiology technologies
  • Neurovascular – Specialized in multi-site and breakthrough studies for stroke, embolic, and cerebrovascular interventions
  • Neurology – Proven success in neurological device development, from neurostimulation to adaptive clinical studies and software-based behavioral treatments (i.e. digital therapeutics)
  • Musculoskeletal & Orthopedics – Experienced partner for surgical, regenerative, and orthopedic device trials and post-market programs
  • Aesthetics & Dermatology – Tailored regulatory and clinical strategies for aesthetic and dermatologic innovations
  • Endocrinology, Gastroenterology & Urology – Expertise across metabolic, endocrine, and urologic technologies, including implantable and combination devices
  • Medical Oncology & Radiology – Strategic and operational support for diagnostic, imaging, and interventional oncology solutions, including experience with oncology-specific FDA programs
  • Other Expertise – Broad capabilities across emerging therapeutic areas and next-generation MedTech innovations
doctor and patient with robotic arm
chemist writing down the results in her diary

Global Reach with Local Precision

Avania’s global network combines scale with on-the-ground insight. Our in-country regulatory experts understand regional frameworks, languages, and cultural nuances — ensuring your submission is not only compliant, but positioned for success in each market.

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Client Success & Impact:

Proof of Our Partnership

Avania operates as a seamless extension of your organization, combining transparency, collaboration, and expertise.

Case Study

Cybersecurity Integration Accelerates 510(k) Clearance

Challenge:

A software-enabled cardiac device faced FDA’s new mandatory SBOM requirements, with most submissions receiving Technical Screening holds for non-compliant cybersecurity documentation.

Avania’s Approach:

We implemented FDA’s comprehensive cybersecurity framework from day one, machine-readable SBOMs, cybersecurity testing, and appropriate modeling, and used Q-Submission meeting with FDA to align on security protocols before the formal FDA submission, eliminating typical Additional Information requests.

Outcome:

FDA cleared the device significantly faster than category median, avoiding Technical Screening holds. The accelerated timeline helped the manufacturer to launch ahead of schedule.

For software enabled devices, cybersecurity compliance isn’t just risk mitigation—it’s timeline acceleration.

Case Study

Accelerating Market Entry Through a Breakthrough De Novo Strategy

Challenge:

A breakthrough device faced a lengthy PMA pathway with substantial costs. No predicate existed for 510(k), yet the risk profile didn’t justify full PMA requirements, which could take up to 7 to 8 years to achieve.

Avania’s Approach:

We identified De Novo as viable FDA strategy, leveraging FDA’s evolving position on similar Breakthrough technologies. Through strategic pre-submission meetings, we positioned the device as moderate-risk with a new classification, negotiating limited clinical evidence rather than large pivotal trials.

Outcome:

FDA accepted the De Novo with Breakthrough designation years ahead of PMA timeline, saving substantial costs and multiple years, meaning faster access to the market and patients.

We are experts at achieving Breakthrough Device Designation and taking novel devices to FDA via the De Novo pathway.

Case Study

Removing Clinical Hold to Restart an IDE and Launch Enrollment

Challenge:

An IDE required to start clinical trials was on clinical hold for months due to FDA concerns about training, safety monitoring, and interim analysis protocols, and that is when the team reached out to us.

Avania’s Approach:

We conducted gap analysis, then facilitated a Q-submission with FDA, presenting revised protocols and pre-specified analyses. Our FDA experience enabled framing solutions in the agency’s benefit-risk language.

Outcome:

The Sponsor got what they needed to move the IDE forward into a successful clinical trial fast.

Strategic FDA engagement led by our experienced experts transforms regulatory obstacles.

Two young professionals collaborating on a project

our approach

Our Integrated Approach

Avania operates as a seamless extension of your organization, combining transparency, collaboration, and shared purpose in every engagement. Guided by seasoned regulatory leaders, our teams unite technical depth with commercial perspective to deliver intelligent, actionable strategies. Whether managing full-service submissions or providing targeted support, we adapt to your evolving needs—ensuring quality, compliance, and repeatable success across every project.

Next Steps

Your innovation deserves a faster, smarter path to approval. Partner with Avania — the trusted champion for MedTech regulatory excellence — and navigate every stage with confidence.

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