Your Path to Medical Software (SiMD, SaMD) QMS Compliance
Build audit-ready processes that align with IEC 62304 software life cycle processes, FDA Guidance & IMDRF software working group accord on SaMD, IEC 82304-1 Health software, and Software Cybersecurity.
Whether you need a gap assessment, targeted process improvements, or a full QMS implementation, our experts help you get compliant with confidence.
Expert guidance for medical devices that include software or embedded firmware
Whether you’re developing a new SaMD (Software as a Medical Device) or updating firmware in an existing medical device, the regulatory and technical challenges are significant. We help you build robust, auditable, and compliant software systems — without sacrificing development velocity.
Why Partner With Us?
Delivering software in a regulated medical environment is a balancing act: stringent safety, regulatory, and documentation requirements must coexist with rapid innovation, Agile practices, cloud platforms, and modern architectures. Here’s how we stand apart:
Flexible & Scalable Engagement:
Whether you need a full overhaul, gap assessment, coaching, or audit prep, we scale to your needs and team maturity.
Deep, Hands-on Experience:
Our team doesn’t just advise — we build real medical software and have participated in audits, regulatory submissions, and product launches.
Modern Methodology Meets Compliance:
You don’t have to choose between compliance and agility. We align IEC 62304, ISO 14971, ISO 13485, and cybersecurity needs with CI/CD, Agile, and cloud-native development.
Audit-Ready from Day One:
We help you produce traceability, documentation, and process evidence tailored to your risk class — so you’re ready for FDA, CE Mark, or other regulatory reviews.
Our Services: Software-Enabled Medical Device Consulting
We support medical device companies across the software lifecycle. Key service areas include:
Technical Documentation & Submission Support
We help you author and organize architecture descriptions, V&V reports, design documentation, and interface everything into a coherent technical file ready for regulatory submission.
Process Implementation & Lifecycle Mapping
We build or remediate your software development lifecycle (SDLC) in alignment with IEC 62304, ensuring each phase (planning, requirements, design, implementation, integration & testing, release, maintenance) is properly defined and traceable.
Gap Analyses & Audits:
We assess your current software development practices against regulatory standards and identify gaps. Optionally, we help you remediate these gaps.
Software Risk & Classification:
We assist you in classifying your software (Class A / B / C) per IEC 62304, and linking to system-level risk analyses as required. We structure software risk management strategies and hazard traceability matrices.
Verification & Validation / Test Strategy:
We design test plans, traceability to requirements and risk controls, verification methods (unit, integration, system), and support evidencing compliance.
Cybersecurity & SOUP Management:
We advise on handling Software of Unknown Provenance components, security requirements, threat modeling, patch strategies, and alignment with newer standards (e.g. IEC 81001-5-1).
Change Control & Maintenance:
Post-market software updates, bug fixes, regression impact analysis, versioning, anomaly handling — we create maintainable processes that preserve compliance over time.
How We Work: Pragmatic, Risk‑Based, and Developer-Friendly
OOur process is designed to embed compliance into your development workflow — not treat it as an afterthought. Here’s a typical engagement path:
Discovery & Gap Assessment
We begin by understanding your product, team, current practices, and compliance posture.
Design & Planning
We co-create a tailored plan, defining roles, deliverables, tools, risk classification, and traceability strategies.
Implementation & Coaching
We help your team adopt the new or enhanced practices, integrate them with your toolchain, and provide hands-on coaching (reviews, workshops, check-ins).
Audit Preparation & Submission Support
When the time comes, we assist with readiness reviews, mock audits, responses to audit findings, and regulatory submission support.
Post‑market Support & Improvement
We stay engaged if needed, help with updates, corrections, regulatory changes, continuous improvement, and evolving standards.
Throughout, we emphasize lean documentation, traceability, and risk-based decisions. We only enforce rigor where needed for safety and compliance — minimizing unnecessary burden.