Consulting and Project Management
Our consultants are also experienced business leaders, developers and technical leads who have delivered large-scale medical software systems in FDA and MDR-regulated environments. This combination of practical software expertise and regulatory knowledge ensures that our advice is actionable, compliant, and aligned with real-world development practices.
Not just consultants.
Builders who consult.
Unlike traditional advisory firms, our team has hands-on experience shipping regulated medical software.
Engineering-First Mindset
Our consultants have written production code for FDA-cleared and CE-marked devices. Advice grounded in real delivery experience, not just frameworks.
Regulatory + Technical Fluency
We bridge the gap between your development team and regulatory requirements — so compliance doesn't become a bottleneck.
Budapest & Singapore
With offices in Europe and Asia, we support international market entry and time-zone coverage for global teams.
Senior consultants,
hands-on experience
Every engagement is led by a senior consultant — not delegated to juniors.
Péter Török, MBA
Dr. Linda Szántó
András Török, MBA
Tamás Fodor
Trusted by industry leaders
Medical Device Software Consulting
Six practice areas covering the full lifecycle — from regulatory strategy to market launch.
1. Regulatory Strategy & Compliance
- FDA 21 CFR Part 820 & EU MDR 2017/745 guidance
- Risk management (ISO 14971), usability (IEC 62366)
- Cybersecurity (IEC 62443), HIPAA/GDPR compliance
- Regulatory documentation & submission packages
3. SDLC Optimization
- QMS and development process integration
- Automated testing pipelines (CI/CD) with traceability
- IEC 62304 compliant development workflows
- Quality assurance standards & documentation
2. Product & Technology Strategy
- Software architecture evaluation for scalability
- Cloud-native infrastructure for SaMD & imaging
- Legacy modernization & API standardization
- AI/ML implementation for diagnostics & CDSS
4. Market & Commercial Strategy
- International market entry (Europe & Southeast Asia)
- Go-to-market plans & product launch strategy
- Post-launch scaling with clinical insights
- Strategic planning for new software products
5. Team & Organizational Development
- Agile coaching for self-organizing teams
- Leadership development & shadow coaching
- Cross-functional collaboration frameworks
- Mentoring for technical and product leads
6. Specialized Advisory
- Medical device interoperability (DICOM/PACS, HL7/FHIR)
- Clinical workflow optimization
- HIS/RIS/OIS integration
- Risk management & cybersecurity guidance
From first call to measurable results
Discovery Call
We learn about your product, regulatory context, and challenges. Free, no commitment.
Assessment
Gap analysis of your current processes, architecture, and compliance posture.
Roadmap
Actionable plan with priorities, milestones, and clear ownership for each workstream.
Execution & Support
Hands-on implementation support, reviews, and ongoing advisory as you scale.
Free: SaMD Regulatory Compliance Checklist
A practical checklist covering FDA and EU MDR requirements for Software as a Medical Device. Built from years of hands-on experience in regulated environments.
Common questions
Everything you need to know about working with our consulting team.
What does a typical consulting engagement look like?
Most engagements start with a free discovery call, followed by an assessment phase. From there, we create a tailored roadmap and provide hands-on support — either as a fractional advisor or embedded within your team.
Do you only work with medical device companies?
Our core expertise is in FDA/EU MDR regulated medical device software. However, our technology strategy, SDLC optimization, and organizational development services apply to any regulated software environment.
Can you help with an ongoing FDA submission?
Yes. We regularly join projects mid-stream to help prepare regulatory documentation, fix compliance gaps, and support submission processes. The earlier we get involved, the more impact we can have.
What is the cost of your consulting services?
Pricing depends on scope, duration, and the level of expertise required. We offer both project-based and retainer models. Book a discovery call and we'll provide a tailored proposal.
Do you work remotely or on-site?
Both. We support fully remote engagements across time zones, with on-site workshops available in Budapest and Singapore. Hybrid models are our most common setup.
Ready to talk?
Book a free, no-commitment discovery call with one of our senior consultants.
