Medical Device Regulatory Consulting Services: Accelerating Market Success

Trusted partner for biotech, pharmaceutical, and medtech innovators navigating FDA, EU MDR/IVDR, and global market approvals.

• 100% success rate across 250+ FDA CDRH submissions
• 30+ FDA Special Designations granted
• Proven expertise from “back of the napkin” concepts through full commercialization

QNova LifeSciences provides comprehensive medical device regulatory consulting services designed to reduce risk, accelerate approval timelines, and ensure compliance in the U.S. and global markets.

Why Choose QNova LifeSciences (Experience, Results, Global Reach)

Our advantage lies in:

• Deep FDA Expertise: Former FDA advisors, regulatory strategists, and global consultants with decades of experience.
• Unparalleled Track Record: Over 250 successful Class I & II submissions and extensive “first-in-class” product approvals.
• Integrated Global Strategy: Harmonized pathways for FDA, EU MDR/IVDR, UKCA, Canada, and Asia.
• Comprehensive Support: From regulatory strategy and quality management to commercialization and investor readiness.
• Single Point of Contact: Streamlined communication across all phases of development.

Global Regulatory Approach (Strategic Roadmaps for Market Entry)

QNova builds tailored regulatory roadmaps aligned with your business objectives:

• Integrated approach across regulatory, clinical, reimbursement, quality, compliance, and cybersecurity.
• Efficient documentation reuse across multiple markets to minimize costs and time-to-market.
• Global market entry roadmaps covering FDA, EU MDR/IVDR, Japan PMDA, Canada, and ROW submissions.
• Evidence-generation strategies supporting payer, regulator, and investor requirements.

Core Regulatory Services (From Concept to Commercialization)

US FDA Consulting

• Regulatory pathways: PMA, 510(k), De Novo, IDE, Q-Sub, Pre-Submission meetings
• FDA establishment registration & UDI submissions
• Comprehensive 510(k) file preparation and testing support
• Regulatory due diligence for M&A and investment readiness

Combination Products & Drug-Device Consulting

• Regulatory pathway assessments for drug-device combination products
• FDA guidance on human factors testing and usability
• Preclinical and CMC integration with device development

Strategic Planning & Execution Services (Beyond Compliance)

• Gap Assessments to identify missing regulatory, safety, or CMC elements
• Predicate device assessments and hazard analyses
• Regulatory due diligence for investors and acquisitions
• Market access strategies and pricing/reimbursement planning
• Comprehensive documentation support for regulatory submissions

Quality Management Systems (QMS & Audit Readiness)

• ISO 13485 and 21 CFR Part 820 compliance
• Risk management per ISO 14971
• SOPs, document control, supplier qualification
• CAPA, nonconformance, deviation management
• Inspection and audit preparedness
• Process mapping and risk reduction strategies

Therapeutic & Device Specialties

QNova’s expertise spans a wide spectrum of medical technologies:

• Devices: Diagnostic tests, imaging, IVD, wearables, implants, AI-integrated systems, surgical tools, delivery platforms.
• Therapeutics: Oncology, cardiology, neurology, infectious disease, autoimmune, rare/orphan diseases, women’s health, and more.
• Digital Health & Software as a Medical Device (SaMD).
• Biologics and advanced therapies: Gene therapy, cell therapy, biosimilars.

Frequently Asked Questions (FAQs)

What are medical device regulatory consulting services?
These services guide manufacturers through complex regulatory pathways to ensure devices meet safety, efficacy, and compliance standards.

Does QNova help with FDA 510(k) submissions?
Yes. QNova has a 100% success rate in over 250 FDA 510(k) and Class II device submissions.

Does QNova provide FDA meeting preparation?
Yes, including Q-Sub, Pre-Submission, and interactions with FDA reviewers to align on strategy.

Can QNova act as a U.S. FDA Agent?
Yes, for non-U.S. companies requiring representation before the FDA.