Our Services
Our Services
Product Development Strategy & Design Control Alignment
Early-stage product development planning grounded in engineering rigor
Translation of user needs and clinical inputs into clear, traceable design requirements
Integration of surgeon and clinical stakeholder feedback into structured voice-of-customer inputs
Alignment of clinical workflows with technical, quality, and regulatory development pathways
Integrated risk management frameworks following ISO 14971
Design control pathway mapping (inputs, outputs, verification, validation, DHF structure)
Technical documentation strategy to support concept-to-clearance alignment
Patient-specific design and manufacturing workflow optimization
Regulatory Strategy & Pathway Planning
Regulatory pathway analysis grounded in long-term development and commercialization strategy
Predicate device evaluation and evidence strategy for 510(k) submissions
Regulatory readiness assessments for Class I–III devices including patient-matched and additively manufactured devices
Pre-submission (Q-Sub) planning and FDA meeting strategy
Support for FDA interactions across CDE, Compassionate Use, HDE, and IDE pathways
Custom Device Exemption (520(b)) strategy and compliance alignment
SaMD classification and regulatory pathway planning for software and AI/ML-enabled medical devices
IEC 62304 software lifecycle planning and compliance strategy
Reimbursement pathway assessment and alignment with regulatory strategy to support sustainable market access
Technical, Engineering, & Advanced Manufacturing Guidance
Design for manufacturability (DFM) reviews for additive, hybrid, and conventional manufacturing methods
Material, process, and engineering strategy guidance tailored to implantable and patient-specific devices
Feasibility assessments for patient-specific implants, AM components, and complex geometries
Verification and validation strategy development informed by mechanical, functional, and usability requirements
Engineering documentation aligned with regulatory expectations and quality system requirements
CAD/CAM workflow refinement and modeling guidance supporting efficient, compliant development of patient-matched and additively manufactured devices
Manufacturing process transfer planning including IQ/OQ/PQ strategy and site readiness assessment
Design transfer and scale-up support across internal production and contract manufacturing partners
Quality & Compliance Support
Design history file (DHF) development, organization, and remediation
Quality system strategy tailored for early-stage companies across hardware and software device programs
Process documentation supporting FDA readiness and inspection expectations
Integration of design, regulatory, and quality frameworks to support scalable growth
Gap analysis and corrective action planning across design controls and technical files
Software quality planning aligned with IEC 62304 and FDA software guidance expectations
Submission Development & Technical Documentation Support
Design history file (DHF) development, organization, and remediation
Quality system strategy tailored for early-stage companies across hardware and software device programs
Process documentation supporting FDA readiness and inspection expectations
Integration of design, regulatory, and quality frameworks to support scalable growth
Gap analysis and corrective action planning across design controls and technical files
Software quality planning aligned with IEC 62304 and FDA software guidance expectations
Regulatory Due Diligence, Acquisition & Technology Transfer
Structured regulatory assessments for investors, acquirers, and strategic partners evaluating medtech assets
Submission gap analysis and FDA correspondence review to identify regulatory risk in target companies
Technology transfer readiness assessments including documentation integrity and design history file review
Manufacturing transfer evaluation across process validation status, quality system alignment, and site readiness
Regulatory pathway assessment for pipeline products to support informed deal decisions
Post-acquisition regulatory integration planning and compliance continuity support
Webster MedTech Consulting is a member of the Maine Technology Institute - Maine Entrepreneurial Resource Corps
Your business may be eligible for subsidized consulting fees of up to $15,000/year or $30,000 over the lifetime of the business