- Strategic Regulatory Advising
- FDA Pre-submissions, 510(k), De Novo, Breakthrough Designation, PMA, EUA, MDDT, STeP
- Q-sub Meeting Preparation & Facilitation
- Predetermined Change Control Plan (PCCP) Strategy & Approval
- Multi-reader, Multi-case (MRMC) Study Design & Regulatory Alignment
- Verification & Validation (V&V) Planning for Regulatory Filing
- Marketing Claims and Regulatory Risk Assessment
- International Regulatory Support (CE Mark)
- Regulatory Due Diligence
- Human Factors Study →
Services Provided:
We help you get ahead of regulatory complexity with sound strategy, focused planning, and precise execution. Whether you’re early in development or facing a major milestone, we guide your team through FDA pathways, submission timelines, and risk assessments with calm, expert clarity.
Chart the clearest path to clearance.
Regulatory Strategy and Submissions
- Human Factors Engineering (HFE) plan development
- Use-related risk analysis and critical task identification
- Summative usability study design and protocol development
- Analysis and final report aligned with FDA expectations (per FDA HF Guidance and IEC 62366)
- Integration of findings into 510(k), or De Novo submissions
Services included:
We help you design FDA-aligned human factors studies to demonstrate safe and effective use of your device.
Human Factors Study
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- Internal Audit Service
- Cybersecurity Risk & Documentation
- QMS Design & Implementation
services Provided
We help early-stage companies establish compliant quality systems that grow with them. Whether you're building from scratch or preparing for an audit, we make ISO 13485 and FDA QSR expectations achievable with documentation, tools, and hands-on guidance.
Create scalable, audit-ready systems- without overbuilding.
Quality Systems & Compliance
- QMS setup aligned with ISO 13485 and 21 CFR Part 820
- SOPs and process templates tailored for SaMD, SiMD, and digital health
- Design History File & Technical File Support (SaMD & SiMD)
- Templates & SOPs Tailored to Startup Needs
- GMLP-Aligned Procedures for AI/ML Devices
Services included:
QMS Design & Implementation
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- Threat Modeling & Risk Assessment
- Cybersecurity Documentation for Regulatory Filing
- Cybersecurity risk documentation aligned with premarket FDA guidance
- Structured documentation for inclusion in regulatory submissions
Services included:
Cybersecurity Risk & Documentation
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- Certified to conduct internal audits aligned with ISO 13485:2016, FDA 21 CFR Part 820, and MDSAP requirements
- Audit planning and execution tailored to your size, stage, and risk profile
- Gap Assessments & CAPA Support
- Pre-Audit Readiness Reviews
- Supplier Audit Strategy
Services included:
Internal Audit Service
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- Clinical Development Roadmapping
- Pivotal, Prospective, and Retrospective Study Design
- Multi-Reader, Multi-Case (MRMC) Study Protocols & Reporting →
- Statistical Input and FDA Engagement Support
- IDE Submissions & Clinical Justifications
- Protocol Writing
- Human Factors Study Planning
- Evidence Strategy for FDA & CE Mark Submissions
Services Provided:
We specialize in designing studies that are right-sized, regulator-aligned, and tailored to your product stage, so you can generate meaningful evidence without overextending time or budget. From pivotal studies to retrospective analysis, we bring both strategy and hands-on design support.
Build the right evidence for your innovation.
Clinical Study Design & Evidence Strategy
- Protocol development for MRMC studies aligned with FDA guidance
- Reference standard and adjudication planning
- Endpoint definition and justification
- Powering and statistical guidance (with partners, as needed)
- Analysis plan and regulatory-compliant reporting
included:
For imaging and software-based devices, we offer deep expertise in multi-reader, multi-case (MRMC) studies.
MRMC Study Design & Execution Support
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