Medical Device Regulatory Consulting: Accelerating Global Compliance

• 250+ successful FDA Class I & II submissions with 100% success rate
• 30+ FDA Special Designations secured
• Extensive experience across diagnostics, imaging, wearables, software, and AI-enabled devices
• Proven support for “first-in-class” and complex technologies

QNova LifeSciences provides tailored medical device regulatory consulting services to minimize risks, shorten approval timelines, and enable commercialization success worldwide.

Introduction & Value Proposition

• Global partner for U.S. FDA, EU MDR/IVDR, UKCA, and Canada approvals
• Deep expertise in FDA submissions, CE certifications, ISO compliance, and MDSAP
• Balanced approach: optimizing the benefit-risk ratio while ensuring compliance
• Dedicated support for start-ups and early-stage developers with time-to-market pressures
• Comprehensive services spanning strategy, submissions, quality systems, and commercialization

Why Choose QNova LifeSciences

• Proven Track Record: 250+ FDA submissions, 65+ drug approvals, 30+ FDA designations
• Multidisciplinary Experts: Regulatory strategists, QA/RA consultants, engineers, biocompatibility experts, medical writers, and scientists
• Core Differentiators:
  • Single point of contact from discovery through commercialization
  • Transparent communication and milestone-based project management
  • Validated QMS compliant with ISO 13485 and 21 CFR 820
  • U.S. market entry and commercialization strategy support
  • Global clinical site network integration
• Client-Focused Approach: Fair, transparent pricing and on-time delivery

Our Expertise & Services

US FDA Consulting

• Regulatory pathway strategy: 510(k), PMA, De Novo, IDE
• FDA Pre-Submission (Q-Sub) meeting planning and execution
• FDA eSTAR/PreSTAR template submissions
• FDA Establishment Registration & UDI submissions
• U.S. FDA Agent services for non-U.S. companies
• Substantial Equivalence (SE) analysis and predicate device assessment
• Verification & Validation (V&V) testing plan design
• Weekly project management meetings for submission oversight

Global QA/RA Compliance

• QMS implementation aligned with FDA QSR, ISO 13485, and MDSAP
• Comprehensive QMS audits and inspection readiness
• Post-market surveillance and reporting systems
• Combination product compliance
• GMP certification & 21 CFR 820 compliance guidance

Biological Safety Consulting

• Biocompatibility testing coordination & strategy

Market Research & Commercialization Support

• Regulatory pathway & market entry strategies
• Pricing, reimbursement, and competitor landscape analysis
• Customer insights and global commercialization planning
• Investor readiness and U.S. soft-landing support

Additional Regulatory Services

• Drug-device combination product consulting

Pricing & Timelines

• Estimated 510(k) preparation cost
• Standard consulting & turnkey QMS pricing options
• Average clearance timelines: 90–180+ days depending on classification
• Common delays: missing pre-submission meetings, repeated testing
• FDA user fees with small business discounts (FDA Form 3602N)

Project Management Approach

• Weekly milestone check-ins with client teams
• Coordination of testing reports (sterilization, sensitization, electrical safety, etc.)
• Transparent communication to avoid costly project delays

Meet Our Experts

QNova’s team includes:

• Former FDA reviewers and global regulatory advisors
• Biocompatibility specialists and QA/RA consultants
• Clinical strategists and medical writers
• Leadership with decades of device approval success

Why Clients Choose QNova

• 100% success rate across 250+ FDA Class I & II submissions
• Transparent, milestone-based project management
• Integrated solutions: regulatory, quality, clinical, commercialization
• Proven ability to support “first-in-class” technologies
• Long-term relationships with startups and global enterprises

FAQs

What is medical device regulatory consulting?
It guides device developers through FDA, MDR/IVDR, and global regulatory pathways to market approval.

Does QNova support FDA 510(k) and De Novo submissions?
Yes, we provide strategy, preparation, and submission management for both.

Does QNova provide FDA U.S. Agent services?
Yes, we act as authorized U.S. representatives for international companies.

Can QNova help implement Quality Management Systems?
Yes, our QMS consulting ensures compliance with ISO 13485, FDA QSR, and MDSAP.

Does QNova provide commercialization support?
Yes, including market entry, pricing, reimbursement strategy, and investor readiness.