From combination products and regulatory strategy to human factors and grant writing — our subject matter experts deliver specialized knowledge across every stage of the medical device and pharmaceutical lifecycle.
PMOA Determination & RFD SubmissionsNavigate FDA's Primary Mode of Action determinations and Requests for Designation for drug-device combination products
End-to-End Drug-Device DevelopmentAlign drug formulation, device design, and regulatory strategy from feasibility to design transfer across all combination product types
CMC & Device Integration StrategyDe-risk development by integrating CMC strategy into device selection and program planning for autoinjectors, inhalers, prefilled syringes, and drug-eluting devices
Regulatory Compliance (21 CFR Part 3 & 4)Expert guidance on FDA combination product regulations, constituent part requirements, and marketing authorization pathways
Post-Market Lifecycle ManagementChange control, design change management, post-market surveillance, and global compliance for approved combination products
Combination Products
At the forefront of innovation, our expertise in Combination Products sets us apart. Defined by FDA CFR Part 4, combination products represent a unique intersection of drug, device, and/or biologic elements. Our team excels in synthesizing these elements, ensuring your combination product meets rigorous FDA and global standards while advancing the frontier of patient care. We have guided 100+ products through development and approval across all major therapeutic areas.
AutoinjectorsPrefilled SyringesInhalers/DPIsDrug-Eluting DevicesRFD/PMOA21 CFR Part 3 & 4Drug-Device-Biologic
Design History File (DHF) CreationBuild compliant, audit-ready DHFs from scratch for new devices and combination products per 21 CFR Part 820 and ISO 13485
Design Input & Output DocumentationTranslate user needs into verified design inputs and traceable outputs with complete design traceability matrix
Design Verification & Validation (V&V)Protocol development, execution, and reporting for design verification and validation activities
Design TransferEnsure smooth transfer of designs to manufacturing with complete documentation and process validation
Design Change ControlSystematic evaluation, documentation, and regulatory impact assessment for all design changes
Design Controls
Robust design controls are the backbone of every successful medical device. Our team brings deep hands-on expertise in 21 CFR Part 820 Subpart C design controls, guiding companies from user needs through design transfer with complete, audit-ready documentation. We help ensure your device is safe, effective, and compliant from concept through commercialization.
21 CFR Part 820ISO 13485DHF CreationV&V ProtocolsDesign TransferTraceability Matrix
Risk Management File (ISO 14971)Complete risk management files per ISO 14971:2019 including hazard identification, risk estimation, risk evaluation, and benefit-risk analysis
FMEA / DFMEAFailure Mode and Effects Analysis for device design and process, including severity, occurrence, and detectability scoring
Use-Related Risk AnalysisSystematic identification of use errors and hazardous situations per FDA HF guidance and IEC 62366
Risk-Benefit DeterminationDefensible benefit-risk analyses for regulatory submissions and design decisions
Effective risk management is fundamental to device safety and regulatory approval. Our experts have authored hundreds of risk management files and FMEAs for medical devices, combination products, and IVDs. We apply ISO 14971:2019 rigorously to produce defensible, audit-ready risk documentation that satisfies FDA, Notified Bodies, and EU MDR requirements.
ISO 14971:2019FMEA/DFMEAUse Risk AnalysisBenefit-RiskPost-Market RiskIEC 62366
Concept Development & FeasibilityTranslate clinical or commercial needs into viable device concepts with feasibility studies and technology assessments
Mechanical & Systems EngineeringFull mechanical design, CAD modeling, prototyping, and systems engineering for medical devices and combination products
Prototype Development & TestingRapid prototyping and iterative testing to validate design concepts before committing to final specifications
Design for Manufacturability (DFM)Optimize device designs for reliable, cost-effective manufacturing from early development through design transfer
Combination Product IntegrationSpecialized device design and development for drug-device, biologic-device, and drug-biologic-device combination products
Design & Development
From napkin sketch to validated design, our engineering team brings deep product development expertise to medical devices and combination products. We leverage a 2,000 sq. ft. design lab for hands-on V&V activities and integrate regulatory requirements from day one so your development path leads directly to market authorization.
Integrated Project PlanningComprehensive project plans integrating regulatory milestones, development gates, and resource requirements
Stage-Gate & Phase Review ManagementDesign and facilitation of phase review processes aligned with FDA design control requirements
Risk-Based Timeline ManagementProactive risk-based scheduling that anticipates regulatory and technical risks before they impact critical path
Cross-Functional Team LeadershipExperienced PMs who bridge engineering, quality, regulatory, clinical, and commercial teams effectively
Regulatory Submission CoordinationEnd-to-end coordination of regulatory submission preparation across multiple functional contributors
Project Management
Medical device and combination product projects require project managers who understand both the technical and regulatory landscape. Our PMs bring direct industry experience managing complex, multi-disciplinary programs from concept through FDA submission and commercial launch — keeping teams aligned, timelines on track, and quality front and center.
Quality Management System (QMS) ImplementationBuild or remediate QMS per ISO 13485, 21 CFR Part 820, and EU MDR requirements from ground up
CAPA SystemsCorrective and Preventive Action process design, root cause analysis, investigation support, and effectiveness verification
Post-Market Surveillance & Complaint HandlingRisk-based PMS programs with experience across 25,000+ complaint handling programs
Audit Readiness & FDA Inspection PreparationFDA audit preparation, mock audits, internal audits, supplier audits, and gap assessments
Design AssuranceEnsure devices and combination products are safe, effective, and compliant from concept through commercialization
Quality Assurance
Quality is not just a regulatory requirement — it is the foundation of patient safety and product success. Our risk-based, patient-centric approach draws on deep regulatory knowledge and technical skill developed across thousands of quality events. We work with your team to close gaps quickly, implement sustainable processes, and build quality cultures that pass inspections and protect patients.
ISO 1348521 CFR 820QSRCAPAPost-Market SurveillanceComplaint HandlingAudit Prep
510(k) Premarket NotificationSubstantial equivalence determinations, predicate device selection, and full 510(k) submission preparation
PMA (Premarket Approval)End-to-end PMA strategy, modular submissions, panel meetings, and FDA negotiation support
IND / NDA / BLA SubmissionsInvestigational New Drug, New Drug Application, and Biologic License Application preparation and FDA interaction
FDA Interaction & Pre-Sub MeetingsLead pre-submission meetings, Q-submissions, respond to 483s, Warning Letters, and Complete Response Letters
EU MDR / CE MarkTechnical documentation, EU MDR/IVDR compliance, Notified Body interactions, and EU market authorization strategy
De Novo & Breakthrough DeviceStrategy and preparation for De Novo requests and Breakthrough Device Designation applications
Regulatory Affairs
Practical, executable regulatory strategies for drugs, devices, biologics, and combination products. Our regulatory affairs experts have navigated hundreds of FDA submissions and interactions across all device classes and therapeutic areas. We develop pathways tailored to your commercial goals and guide your team through every step from pre-submission to clearance or approval.
Formative & Summative HF StudiesDesign, conduct, and report global human factors studies demonstrating safe and effective device use per FDA guidance
Use Error Risk AnalysisSystematic identification and mitigation of use-related risks per FDA HF guidance, IEC 62366, and ISO 14971
Usability Engineering FileComplete usability engineering documentation package for FDA, EMA, and Notified Body submissions
Task Analysis & User Interface DesignSystematic task analysis and user interface design optimization to reduce use error risk
HF Regulatory StrategyNavigate complex global HF submission requirements across FDA, EMA, Health Canada, and other regulatory bodies
Human Factors Engineering
Human factors engineering is increasingly central to FDA clearance and approval. Our HF team specializes in designing and executing formative and summative studies, preparing complete usability engineering files, and navigating complex global HF regulatory requirements for pharma, biotech, and medical device companies — including combination products.
DHF Gap AnalysisSystematic assessment of existing DHFs against current FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements
DHF Remediation ExecutionHands-on authoring and remediation of all DHF deliverables including design plans, risk files, V&V protocols, and design transfer documentation
Risk Prioritization & RoadmapRisk-based prioritization of remediation activities to maximize compliance in the shortest time with available resources
FDA & CE Inspection ReadinessProven track record of remediated DHFs passing FDA and CE-related inspections for combination products and medical devices
Post-Remediation QMS IntegrationIntegrate remediated DHF processes into ongoing QMS to prevent recurrence and sustain compliance
DHF Remediation
DHF remediation done poorly leads to significant rework and financial impact. Our team has remediated many product files for combination products and medical devices that have passed FDA and CE-related inspections. We lead the remediation process from gap analysis through final audit-ready documentation, ensuring it is completed right the first time.
DHF Gap AnalysisDocument Authoring21 CFR Part 820EU MDRAudit ReadinessFDA Inspection
NIH SBIR Phase I & II Grant WritingEnd-to-end grant writing for National Institutes of Health Small Business Innovation Research programs — strategy, writing, and submission
NIH STTR GrantsSmall Business Technology Transfer grant applications connecting your company with academic research partners
Federal Grant StrategyAgency identification, program fit analysis, and grant strategy for NSF, DOD, HHS, and other federal programs
State & Nonprofit FundingIdentification and application support for state economic development grants and nonprofit foundations
If you are looking to fund your small company or startup, non-dilutive NIH SBIR and STTR grants are one of the best options available. Our Director of R&D and Non-Dilutive Grant Funding has raised millions for medical device startups through successful NIH grant applications. With PhD-level bioengineering expertise, we translate your technology into compelling, funded science.
V&V Statistical AnalysisSample size justification, acceptance criteria derivation, and statistical analysis for verification and validation studies
Sampling Plans & AQLRisk-based sampling plan design per ANSI/ASQ standards for incoming inspection, process control, and final release
Process Capability & SPCProcess capability studies (Cp, Cpk), statistical process control charts, and measurement system analysis (MSA/Gage R&R)
Clinical Data AnalysisStatistical analysis of clinical study data, equivalence/non-inferiority testing, and clinical evidence summaries
Shelf Life & Accelerated AgingStatistical design and analysis of real-time and accelerated aging studies for device and combination product shelf life
Statistics
Sound statistical methodology underpins every credible medical device submission. Our biostatisticians and engineers provide rigorous statistical support across V&V, clinical studies, sampling plans, and process validation — producing defensible analyses that satisfy FDA reviewers and Notified Bodies.
Sample Size JustificationV&V StatisticsSampling PlansProcess CapabilityClinical StatisticsShelf Life
Regulatory Strategy & RoadmapDefine your FDA regulatory pathway from day one — device classification, predicate strategy, and submission planning aligned with your business goals
IP & Competitive LandscapeFreedom-to-operate analysis, patent landscape review, and competitive device assessment to inform development strategy
Investor & Due Diligence SupportPrepare regulatory and technical due diligence packages that satisfy investor, acquirer, and partner requirements
Quality System FoundationRight-sized QMS implementation for early-stage companies — compliant from the start without over-engineering
Milestone & Fundraising PlanningRegulatory milestone planning that aligns with fundraising rounds, partnership timelines, and commercialization goals
Startup Business
Medical device and combination product startups face unique challenges navigating FDA requirements with limited resources. Our startup consulting team provides strategic guidance on regulatory pathways, QMS foundations, grant funding, and investor readiness — helping early-stage companies build the right foundation for commercial success.