When you need more than a single consultant, our integrated solutions deliver coordinated teams, proven methodologies, and accountability at every step.
We provide comprehensive end-to-end management for combination product development — from initial concept and regulatory strategy through design, development, human factors, clinical studies, and commercial launch. Our integrated team replaces 50+ fragmented suppliers with a single accountable partner that seamlessly manages all aspects of your combination product program.
What's Included
Regulatory Strategy & PathwayPMOA determination, RFD submissions, FDA pre-sub meetings, and full submission strategy (510k/PMA/NDA/BLA)
Device Design & DevelopmentMechanical engineering, systems engineering, prototyping, V&V, and design transfer in our design lab
CMC IntegrationChemistry, Manufacturing & Controls strategy integrated with device development and regulatory planning
Human Factors & UsabilityFormative and summative HF studies, use error analysis, and complete usability engineering file
Quality & ComplianceQMS implementation, risk management, post-market surveillance, and audit readiness throughout
DHF remediation can have a major impact on your organization. If not completed properly, the significant rework that usually follows has a major financial impact to your bottom line. Make sure you get it completed right the first time by letting us lead the way. We have remediated many product files for combination products and medical devices that have passed FDA and CE-related inspections.
Deliverables We Specialize In
Design ControlsDesign & Development Plan, User Needs, Design Inputs/Outputs, Traceability Matrix, V&V Protocols & Reports, Design Transfer
Risk ManagementRisk Management Plan, Risk Management Report, FMEA/DFMEA, Use-Related Risk Analysis per ISO 14971:2019
Regulatory DocumentationTechnical files, 510(k) summaries, design dossiers, and other regulatory submission artifacts
Gap Analysis & RoadmapSystematic gap analysis with prioritized remediation roadmap and resource planning
Gap AnalysisDocument AuthoringRisk PrioritizationFDA Inspection ReadyEU MDR
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Quality System Implementation
A well-designed quality management system is the foundation of regulatory compliance and operational excellence. We provide complete design and implementation of ISO 13485 and 21 CFR Part 820-compliant QMS for startups and emerging companies, as well as remediation and optimization of existing quality systems for established manufacturers facing compliance challenges.
QMS Components
SOP DevelopmentStandard Operating Procedures for all required QMS processes including design controls, CAPA, complaint handling, audits, and management review
CAPA SystemCorrective and Preventive Action process design with root cause analysis templates and effectiveness check methodology
Document ControlDocument and record control systems that meet FDA and ISO requirements and scale with your organization
Training ProgramQMS training program design and initial staff training to ensure effective implementation
ISO 1348521 CFR 820SOPsCAPADocument ControlTraining
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End to End Product Development
Your complete outsourced R&D and regulatory organization. From concept through commercial launch, we manage every aspect of product development — engineering, design controls, risk management, verification and validation, regulatory submission, and design transfer — with full documentation at every stage. Purpose-built for companies that need to move fast with limited internal resources.
Design DevelopmentComplete engineering design with design controls, risk management, and design reviews throughout
Verification & ValidationV&V protocol development, test execution in our design lab, and comprehensive reporting
Regulatory Submission & Design TransferComplete FDA submission package and validated design transfer to manufacturing
Concept to MarketDesign ControlsV&VRegulatoryDesign TransferFull Documentation
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Outsourced Partner
For companies that want expert support without the overhead of a full internal team, our Outsourced Partner model provides flexible, on-demand expertise that integrates seamlessly into your organization. We become a true extension of your team — embedded in your culture, aligned with your processes, and scaling capacity as your program demands evolve across development, regulatory, quality, and clinical functions.
Engagement Models
Embedded ConsultingOur consultants work as part of your team — attending your meetings, using your systems, and owning deliverables
Staff AugmentationScale your team up or down as programs require without the cost of permanent headcount
Functional OutsourcingOutsource complete functions — regulatory affairs, quality, engineering — with accountability for outcomes
Hyper-Virtual Sponsor ModelPurpose-built for startups and venture-backed companies — outsource everything but vision and decision-making
Client needed to launch a new drug-device combination product and remediate the existing DHF on a very tight timeline with resource constraints.
Quantified Gaps
Significant resource gap — two additional full-time contract resources needed with specific DHF remediation and combination product expertise.
Determined Solutions
A principal engineer (~10 years) and senior engineer (1–2 years) recommended to meet demands as efficiently as possible.
Implemented Solutions
Two contractors placed on-site, both immediately offered contracts. Both exceeded client expectations, delivering consistent results throughout.
New R&D Organization Build-Out with QMS & CE Mark
Consulting+
Identified Needs
Medical device company needed a world-class R&D organization with robust quality systems, efficient design control processes, and FDA/EU-compliant DHFs from day one.
Quantified Gaps
Gap in SME expertise for product development, design controls, risk management, and project management as the new team was being built.
Determined Solutions
Flexible hourly consulting contract to fill SME gaps while the internal team was assembled, with ongoing quality system and project documentation creation.
Implemented Solutions
Compliant DHF created and first device launched within 3 months. Supported CE Mark expansion into EU. Led three device configurations to launch in four months.
Ready for an Integrated Approach?
Let us build you a solution as comprehensive as your challenge.