Measured in value,
delivered in days.
As an entrepreneur, you are building a product, a team, and a business at the same time. Regulations like MDR and the AI Act, or even something as simple as the wording of your intended use, can feel like distractions or roadblocks - or may materialize as such, even if you don’t want. Having been there, we know how to support you pragmatically at the right time. Make regulation work for you when you need it, not against you.
Our offerings are designed to give you grounded, actionable clarity in days with only a few hours of your time. You get answers you can defend, materials you can show to investors and partners, and practical next steps that fit your stage.
No heavy systems or processes before you need them. No unnecessary hires. No wasted spend. just what you need right now to keep moving forward with confidence.
Thinking as a founder.
Build confidence, quickly. We offer you value at a quality and price level that our competitors cannot match. Why? Because we know how hard it is to build a company in this space. Because we care.
Interested in hiring a (fractional) CTO/CTPO/CPO? Contact us!
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Is your Intended Use Statement (IUS) wording robust enough for your current and future strategic and commercial ambitions? Is the current IUS sufficiently covered from a regulatory/evidence perspective? Will the wording hurt the business later?
Description
A concise review and, where necessary, suggested rewrite of your Intended Use Statement (IUS). Rewrite suggestions include a mini MDR fit check. We assess current wording, implied claims, and downstream effects on classification, evidence, and marketing. You receive before and after versions, a short rationale for defensibility, and clean copy you can paste into submissions and materials.
What you get
Before and after version of your Intended Use Statement (IUS)
Short rationale for MDR impact and defensibility
Notes on downstream effects for claims and studies
Ready-to-paste text for submissions, decks, and marketing
Benefits
Prevent accidental up-classification caused by wording
Align product, clinical, and sales on what you can safely claim
Build a reusable claims foundation that keeps teams consistent
Timing and effort: delivered in 2 business days
Typical client time: about 90 minutes -
Description
A focused review of EU Medical Device Regulation (MDR) status that clarifies whether your product qualifies as a medical device and, if so, what class and pathway apply. We analyze intended use, claims, and product design choices to determine the most defensible regulatory position for your stage.Should the facts point to your offering not being a medical device, we will clearly state so. You may use this Not-a-Medical-Device (NaMD) statement with stakeholders.
For a full board-ready assessment, including organisational, procedural and product principles that must be in place to safeguard current (non) classification, see the MDR Strategy Brief.
What you get
Assessment of position with respect to EU MDR, class and supporting rationale, or a NaMD statement
One-slide summary suitable for decks and data rooms
Benefits
Immediate clarity that aligns strategy, commercial, product, and investor expectations
Avoid costly premature compliance work and its consequences on business
Plan realistic timelines and reduce surprises later
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What is your official MDR stance, near-term roadmap, and story for stakeholders? How do you safeguard your current positioning or classification as (not) being a medical device?
Description
A board-ready document that turns positioning into a practical plan. We assess your strategy, product and goals and translate them into actionable guardrails, responsibilities, and a short-term roadmap.
Where relevant, we include an external derivative such as a Not-a-Medical-Device (NaMD) statement or a concise classification note for partners.
What you get
Assessment of position with respect to EU MDR, class and supporting rationale, or a NaMD statement
Organisational, procedural and product guardrails and compliance guidelines
One-slide summary suitable for decks and data rooms
Organisational measures and responsibilities
Near-term roadmap with owners and dates
External derivative (one-pager)
Board-level slide and a three-page summary
Benefits
One source of truth that ends circular debates
Stage-appropriate compliance that scales when you are ready
Stronger confidence from boards, partners, and investors
Timing and effort: Delivered in 5 business days
Typical client time: 2–3 hours -
Is your AI software high-risk, and what is due now versus later? What are the guardrails you need to put in place so you can balance business & commercial needs with your legal & compliance responsibilities.
Description
A fast triage that classifies your system under the EU AI Act and maps obligations over time. We look at functionality, deployment context, human oversight, data use, and interaction with MDR where relevant. You receive a clear yes or no on high-risk status, a timeline of what is required now versus later, and a short action list for product, data, and QA.
What you get
Classification assessment statement under the EU AI Act
Timeline of obligations labelled now, next, later
One-page action checklist
Investor-ready slide
Benefits
Answer AI questions confidently in diligence and sales
Focus budget on what matters today, defer what does not
Reduce legal spend by arriving with a clear internal stance
Timing and effort: delivered in 3–5 business days
Typical client time: about 2 hours
Value.
Bundled.
Maximize value, minimize impact on your organization. Spend your time and money where it matters. Explore our value bundles to gain confidence fast.
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A compact package for early-stage teams that need fast, credible answers. Combines the Medical Device Positioning Scan, AI Act Readiness Scan, and Intended Use Check-up into one integrated review. Outputs are cross-checked to ensure consistency across regulatory, claims, and product positioning.
What you get
All deliverables from the Medical Device Positioning Scan, AI Act Readiness Scan, and Intended Use Check-up including cross-checks
Assessment of position with respect to EU MDR or US FDA, class and supporting rationale, or a NaMD statement
AI Act classification with clear yes/no on high-risk status
Timeline of AI Act obligations (now, next, later)
Before and after Intended Use Statements, with rationale for defensibility
Organisational, procedural and product guardrails and compliance guidelines
Organisational measures and responsibilities
Notes on downstream impact for claims, studies, and reimbursement
Three concise, shareable artifacts suitable for decks, data rooms, and board updates
Why it matters
Avoid overbuilding compliance before it is needed
Enter fundraising and partner meetings with simple, credible answers
Keep the business focused on what creates value
Timing and effort: delivered in 5–7 business days
Typical client time: 4-5 hours
Why choose us.
Speed
We share your founder mentality. We delivery you investor-ready insights in days, not months.
Clarity
Concise, defensible outputs that directly support decision-making.
Proportionality
Findings scaled to the company’s maturity, with no unnecessary noise.
Experience
More than 20 years in medtech and healthtech, translated into practical judgment investors can rely on.
Efficiency
Cost-effective assessments that filter opportunities before heavy diligence is needed.