Expert Guidance
From Concept
to Compliance.
Specializing in medical device software quality assurance, regulatory compliance, product cybersecurity, risk management, and human factors engineering -- so your team can focus on building life-changing technology.
Comprehensive Compliance
& Quality Expertise
From initial design controls through post-market surveillance, we provide the specialized knowledge your team needs to navigate complex medical device regulations.
Hands-on expertise across every layer of medical device compliance.
From IEC 62304 software lifecycle to STRIDE cybersecurity modeling -- done hundreds of times.
Product Software V&V
Verification and validation for software that is part of or controls a medical device. V&V planning, test protocol authoring, execution support, and summary reports aligned to IEC 62304 safety classes B and C and FDA software validation guidance.
Non-Product Software V&V
Validation of software used in manufacturing, inspection, and quality processes that is not part of the device itself -- including production test systems, MES, LIMS, and automated inspection tools -- per FDA General Principles of Software Validation.
System V&V
System-level verification and validation for the complete medical device -- hardware, software, and their integration. System test planning, hardware-software interface testing, design verification and validation protocols, and traceability to design inputs.
Quality Management System
Comprehensive QMSR implementation and remediation aligning your QMS with FDA Quality Management System Regulation. Gap analyses, SOPs, design controls, and audit readiness from document strategy through inspection prep.
Product Cybersecurity
End-to-end security engineering for connected and networked medical devices. Threat modeling using STRIDE, Threat Analysis and Risk Assessment (TARA), Software Bill of Materials (SBOM), and FDA premarket cybersecurity submissions.
Medical Device Software Lifecycle
Full IEC 62304 lifecycle process implementation -- software development planning, architecture, detailed design, integration, verification, and maintenance processes tailored to your device software safety class (A, B, or C).
Health Software Quality
ISO 82304-1 compliance support for standalone health software products. Quality management processes, intended purpose analysis, clinical evaluation, and post-market surveillance planning for SaMD and mobile health applications.
Risk Management
Systematic risk management per ISO 14971 across the full device lifecycle. Risk management plans, hazard identification, FMEA/FTA, risk benefit analysis, and risk management reports supporting regulatory submissions worldwide.
Human Factors Engineering
Structured usability engineering programs per IEC 62366-1 and HE75 guidance. User research, task analysis, use specification, formative and summative studies, use error risk analysis, and FDA/EU MDR submission documentation.
Regulatory Strategy & Submissions
Regulatory documentation support including RFI responses, Notified Body technical reviews, and EU MDR/IVDR technical files. TR 62304 document packages, risk management files, and pre-submission meeting preparation.
The Specialist Difference
in Medical Device Software
Medical device software quality is a niche that demands both technical depth and regulatory precision. We bring specialized expertise that generalist consultants simply cannot match -- with a track record across hundreds of regulatory submissions.
Collaborative. Transparent. Results-driven.
Deep Regulatory Expertise
Our consultants have decades of hands-on experience navigating FDA, EU MDR, and international regulatory pathways specifically for medical device software -- not generalist compliance.
Global Standards Fluency
Mastery of the full interrelated standards ecosystem: IEC 62304, ISO 14971, IEC 62366, QMSR, ISO 82304, TIR-57, and FDA current cybersecurity guidance -- applied cohesively.
Submission-Ready Deliverables
We produce documentation that passes FDA technical reviews. Our templates and outputs are refined through hundreds of successful submissions -- no rework cycles.
Embedded Team Approach
We work alongside your engineering and regulatory teams, transferring knowledge and building internal capability rather than creating dependency.
Speed Without Compromise
Tight timelines are our specialty. We know which shortcuts are acceptable and which introduce regulatory risk -- keeping your program moving without jeopardizing approval.
End-to-End Lifecycle Support
From initial concept and design inputs through post-market surveillance and product changes -- one consistent expert relationship across your device full lifecycle.
A Proven Process for
Regulatory Success
Our structured approach eliminates guesswork and keeps your program on track -- from initial assessment through final regulatory acceptance.
Structured. Transparent. Submission-Ready.
Every step documented to FDA standards, every deliverable reviewed for regulatory defensibility.
Discovery & Gap Analysis
We start with a thorough assessment of your current state -- existing documentation, development processes, quality system maturity, and regulatory requirements for your device classification and intended markets.
Strategy & Planning
Collaboratively build a tailored quality and compliance strategy. We define scope, timelines, resource requirements, and a phased roadmap that aligns regulatory work with your product development schedule.
Implementation & Documentation
Hands-on support developing all required documentation -- software development plans, risk management files, usability files, cybersecurity documentation, and quality system procedures aligned to applicable standards.
Verification & Review
Independent review and verification of all documentation against regulatory requirements. We conduct internal audits, trace matrices, and review cycles to ensure completeness and regulatory defensibility before submission.
Submission & Agency Support
Compilation of complete regulatory submission packages and active support through agency interactions. Includes RFI responses, Notified Body technical review support, and TR 62304 document packages through to final acceptance.
Start Your Path
to Compliance
Whether you're starting a new device program, preparing for an FDA submission, or need to remediate gaps in your existing quality system -- we're here to help. Tell us about your project and we'll respond within one business day.
What to expect:
Expert guidance, personal attention.