Measured in value,
delivered in days.
We help venture funds, corporate investors, and boards evaluate medtech and healthtech opportunities with speed and precision.
Many companies look strong on the surface but carry regulatory or operational risks that only become visible late in diligence.
Our investor-focused offerings provide structured, independent insight early in the process, so you can move faster and with more confidence.
For you as an investor.
Years of experience on both sides of the table. Value delivered quickly and with confidence. Our investor offerings have been used in more than 50 deals by multiple investors.
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Is this company truly investment-ready? Is the product, team and technology ready for the stated ambitions? What risks and opportunities are there?
Description
A structured, proportional review that gives investors and boards an independent view of readiness. Built on the Foundational Readiness Scan / Technology Quick Scan (FRS/QTS) framework, it covers eight domains that commonly determine execution risk and time to scale. An optional extension adds a legal, compliance and regulatory lens on request (especially useful for regulated businesses in e.g. fintech or medtech). The FRS/TQS methodology is built on many years of building, operating and assessing (digital) product and service companies and has been used in 50+ due diligence processes for multiple investors.What we look at
We assess the teams, technology and product in a general business context with an eye on the history, current realities and future ambitions. This includes the current (management) team. From a product and technology perspective, we look at: architecture and technology choices, infrastructure, information security, scalability, availability, and operations, data storage and processing (incl. GDPR-related aspects), software development and quality processes and status and code ownership and intellectual property.
What you get
Clear assessment across domains, proportional to current stage, history and future ambitions
Strengths, weaknesses, and risks, clearly split in board-ready assessment + findings
Prioritised recommendations that inform investment decisions and the company roadmap
Benefits
Accelerate investment committee discussions with objective insight
Reduce risk of late-stage surprises after term sheet
Provide founders and investors a practical, staged improvement plan
Timing and effort: delivered in 5 business days
Typical client time: about 4 hours -
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.
Gain a deeper understanding of your prospect or portfolio to enable you to have more valuable conversations with founders or other stakeholders.
We believe that building mutual understanding over time builds value. Contact us if you are interested in a longer term engagement - we’ll chip in.
Naturally, we’re also happy to support your portfolio companies.
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A cost-effective way for investors and boards to combine breadth and focus. Bundles the Investor Readiness Scan with the Medical Device Positioning Scan (MDR / US FDA) to give a proportional view of team, product, and technology readiness alongside a targeted assessment of the company’s products or service offerings with respect to the EU or US medical device regulations.
What you get
A structured assessment across multiple domains: business context, team, architecture, infrastructure, security, scalability, data, and development quality
Identification of strengths, risks, and proportional recommendations across these domains
MDR/US FDA class assessment with rationale, or NaMD confirmation where applicable
The 5 most important compliance priorities linked to medical device classification
Concise outputs designed for internal decision-making, IC materials, or board packs
Minimal company time requirement, with clarity delivered in under 2 weeks
Why it matters
Apply a consistent standard across opportunities
Identify risks before commissioning heavy diligence
Improve decision speed without compromising quality
Timing and effort: delivered in 5–7 business days
Typical client time: 4-5 hours
Why choose us.
Speed
Like you, we understand speed as well as diligence is important. We deliver 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.