Generic.

What exactly do I receive at the end of an engagement?

Clear, concise artifacts you can use immediately - and of course or promise to provide you with a debrief or a quick follow-up. Certain offerings include e.g. classification rationales, roadmaps, ranked priorities, and one-slide or short-form summaries for decks and data rooms.

Is this legal advice?

While we have years of experience successfully building, operating, transforming and assessing ventures, we are not lawyers. You receive structured assessments and practical recommendations informed by experience, referencing regulations, laws and/or guidelines. Many clients use our outputs to brief counsel or notified bodies, typically significantly reducing external billable hours.

Why not just use AI or search?

We have found that while AI absolutely helps our clients in building knowledge, the challenge quite often is in knowing which question to ask and how to interpret the results. Furthermore, we have found that our experience brings confidence and peace of mind for both ventures and investors.

How do you protect confidential information?

Our experience working in regulated domains has marinated us in the importance of treating information security, privacy and (commercial) sensitivity with the utmost priority. By default, we work with you under an NDA and only request the minimum amount of information needed to deliver. We store any materials we may receive of you securely and retain them only as long as needed for delivery unless you request otherwise.

What if we disagree with a conclusion?

We take great care in constructing our deliverables, but it may happen that we see things differently at the end of the process. Each conclusion or statement we make comes with a rationale. Naturally, if new facts change the picture, we update the output accordingly. The goal is defensible decisions, not fixed opinions.

Do you work outside the Netherlands?

Absolutely. Most of our clients are in the EMEA region (with the gravitas being on EU and UK), but our US FDA experience has been found valuable for clients seeking to cross the pond (either towards US or EU). We can coordinate with local counsel or experts where needed.

For Founders and Ventures.

Will this slow us down?

Having been on your side of the table quite a few times, we know how impactful these processes can be to your organization. Therefore, we designed our offerings so that we minimize the impact on your organization and we do the rest: most offerings require only 60–120 minutes of your time (our interviews are generally online). Due to our structured approach, delivery is measured in days.

Do we need a Quality Management System (QMS) now?

Usually not. You see what is essential at your stage and what can wait. This keeps you lean and focused. However, if you know you will need one later, you may already start implementing parts of the methodology in your current way of working to train your organisation and build up required documentation in a pragmatic, lightweight way for when you need it later.

Can we show these outputs to investors and partners?

Having been on both sides of the table in investment rounds and due diligence processes, we understand the importance of clear and professional documentation. Furthermore, we create the artifacts for you so that they may also provide value in future rounds or data rooms. All outputs are created to be shared, unless you request an internal version only.

What if our product changes next quarter?

Many teams revisit the MDR Positioning Scan or the Intended Use Check-up after a release. We can update the outputs quickly without redoing everything. Based on your strategic or commercial plans or roadmap, we may already plan one of these to give you peace of mind.

What is a Not-a-Medical-Device (NaMD) Statement?

We have found that many organizations struggle to define whether they are, or need to be, a medical device. Where an organization has the liberty to choose, there may be benefits to choose to already pursue certification/registration as a medical device (e.g. commercially), although the impact in terms of time and resources are significant - not only initially but also ongoing. As such, when the facts support this conclusion and the organization chooses not to be a medical device for the time being, a thorough analysis, rationale and conclusion in the form of a ‘Not-a-Medical-Device (NaMD) Statement’ brings confidence to both the internal organization and stakeholders alike.

What happens if we need deeper help after the MDR Strategy Brief?

We’re happy to assist you ourselves or point you to partners. You can use the MDR Strategy Brief as blueprint for the next steps to take.

For Investors.

How does the Investor Readiness Scan (IRS) differ from full diligence?

Our Investor Readiness Scan has been used in more than 50 deals already serving as a broad product, technology & team due diligence. We look at the status of the organisation within the context of where it came from, where it currently stands and where it aims to go. You receive a structured view across key domains in 5 business days, often avoiding heavy spend on companies that are not ready yet.

Can we apply a standard across the portfolio?

Absolutely. Using consistent templates and scoring makes comparisons easier. For longer term engagements, we share our structured, data-driven approach so you can even compare and assess on a more granular level between your portfolios - or to assess over time (an IRS Follow-Up offering is available at a reduced rate).

Can the Investor Readiness Scan include a regulatory lens?

This is where our experience brings our clients the confidence they’re looking for. On request we add an overview of the legal, compliance, and regulatory landscape to complement the core eight domains. We apply the same cross-domain analysis for assess the organization, looking for proportionality, risks and opportunities.

How much company time is required?

About 4 hours across leadership and technical contacts for the Investor Readiness Scan. Less for the MDR Positioning Scan or AI Scan.

How are findings presented?

You receive professional deliverables that you can share with your stakeholders. During the Investor Readiness Scan, we will directly indicate our findings - transparency and immediacy is key in deal flow processes.

Depending on the offering, we do a debrief with you and your stakeholders to provide background information. The objective is always clarity, confidence and actionability. If you have specific needs with respect to the output formats or debriefing, let us know. For the Investor Readiness Scan, we give a debrief immediately after the interview to with a preliminary conclusion to the sponsor.

What if critical issues are found?

Our findings look at present or future risk for the organization. Should any critical findings emerge, we will immediately indicate so. Depending on the finding, clients may decide to continue the interview or postpone and address the findings.

Process and Logistics.

What do you need from us to start?

We aim to minimize the impact on the organization and therefore we’ll request only that which is necessary to create the deliverables. Furthermore, we seek to minimize the time we ask of staff. Depending on the offering we may ask for a brief on the business and intended use, target users and environment, current product state, a high-level architecture of the product/service, and any prior claims already made in sales or marketing.

How does the process work?

Generally it is a simple, three step process: kickoff & briefing, data collection & interviewing and report generation & debriefing. Where required, we’ll make a final version after the debrief with agreed changes.

How quickly can we begin?

Usually within a few business days. Turnaround times listed for each offering start once materials are received.

What formats do you deliver in?

We deliver high-quality PDFs and editable slides for to store in a data room or to share with stakeholders.

Do you revise the deliverables?

If the debrief surfaces factual errors or essential context, we update the deliverable so it reflects the current reality.

What if our needs change mid-engagement?

We keep scope tight to protect timelines. If broader work is needed, we complete the original deliverable and scope a follow-on so momentum is not lost.