Easy13485 transforms regulatory uncertainty into a predictable pathway: faster CE readiness, leaner spend, and audit-grade evidence.
The Regulatory Makerspace keeps founders focused on what matters most — innovation and growth — while we secure the compliance backbone.
When you back a MedTech startup, you don’t just fund innovation — you inherit regulatory execution risk. Delayed certifications, failed audits, and compliance gaps can burn capital and kill otherwise promising ventures. Our Regulatory Makerspace neutralizes this risk: every startup in the program operates with an audit-ready QMS from day one, structured technical documentation, and built-in training that keeps teams compliant as regulations evolve.
The Result: Cleaner diligence signals, higher survival rates, and capital that compounds into market entry instead of regulatory rework.
We give startups a clear pathway to MDR readiness — combining a fast-track QMS, structured documentation, and built-in support. Instead of months of uncertainty and correction loops, you get speed, confidence, and investor-ready compliance from day one.
A pre-configured ISO 13485 system, individually tailored to each startup. Roles, SOPs, and approvals are in place immediately — startups are audit-ready from day one. Easy13485 combines the speed of an out-of-the-box solution with the flexibility to reflect each team’s specific setup.
A built-in training platform with role-based micro-courses, tracking, and certification. Every team member gets the right knowledge at the right time, with built-in evidence for audits. Designed to develop high potentials—like top consulting firms—the Academy turns training into a strategic growth tool.
Technical documentation is embedded in the QMS, supported by structured MDR/ISO templates. Startups stay in the driver’s seat, while regulatory guidance is provided only when needed — consultants are used strategically, not permanently. This approach cuts costs and accelerates submissions. Consultants are used strategically, not permanently.
An AI co-pilot trained on Easy13485. It delivers instant MDR/ISO answers and practical guidance, reducing dependency on costly consultants for routine questions and keeping teams moving without delay. Answers in seconds, so teams stay in flow and budgets stay lean.
Internal audits, mock runs, and CAPA coaching ensure teams stay on track and take the process seriously. By the time they face a Notified Body, startups are prepared to pass confidently and securely — minimizing the risk of costly setbacks. Confidence on audit day—fewer findings, fewer costly loops.
Traditional regulatory projects often spiral into €30–50k for Class I and €70–100k+ for Class IIa, largely due to consultant hours, rework, and uncertainty. Our Regulatory Makerspace approach compresses these costs dramatically: startups operate with a ready-to-use QMS, guided documentation, and AI/academy support that cut both time and burn-rate.
Figures below are indicative estimates based on recent startup projects; actuals vary by device complexity, scope, and Notified Body requirements.
Uncertainty kills investor confidence. That’s why our Makerspace compresses QMS certification into a proven 5-month pathway, combining plug-and-play systems with guided execution. The approach is already field-tested: Caire.ai followed the model and secured ISO 13485 certification within the guaranteed timeframe.
MDR/ISO scope defined, roles assigned, and a concrete roadmap agreed in a single session.
Ready-to-use QMS: pre-filled SOPs, role matrix, and approvals — only minimal tailoring needed.
Design reviews, supplier evaluations, and training evidence captured continuously inside the QMS.
Audit pack prepared; MR & KPIs confirm system effectiveness and readiness for certification.
Nonconformities coached to closure; QMS certified in record time.
“We moved from the decision to go with EASY13485 to CE mark in less than 5 months. For our Class I product, the Makerspace provided exactly the structure and guidance we needed. It wasn’t just fast — it was the quickest, safest way to start generating revenue.”
“Compliance without the cost spiral. EASY13485 made our Class I software conformity predictable and stress-free. Templates and the Academy gave us clean evidence, while keeping our burn low. That clarity gave partners and investors confidence from day one.”
“With IPP’s support we achieved ISO 13485 certification in just 5 months. The process was fast, structured, and completely transparent on costs. For a Class IIa startup like ours, that speed is crucial for our medical device certification timeline.”
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We’ve compiled the most common questions investors ask about Easy13485 and our Makerspace model. From certification timelines to burn-rate impact and due diligence signals, these answers give you clarity on how we reduce risk and accelerate market readiness.
Investors want certainty on execution windows and clarity on external factors influencing certification.
For most start-ups, achieving ISO 13485 certification for a Class IIa medical device typically takes 9–12 months. The main reasons for these long timelines are: creating a QMS from scratch, lack of regulatory expertise within the team, incomplete documentation, and delays in scheduling audits with the Notified Body. Each of these factors can add months and create cost uncertainty.
With Easy13485:
The certification path is more predictable. The QMS is available from day one, so there is no “blank sheet” phase. Teams move through self-paced training in the Academy, while the QMR gradually builds confidence in using the system. After this preparation:
Stage 1 audit takes about one month, including the time to respond to NB questions.
Stage 2 follows shortly after, often in parallel, which keeps the process flowing.
In practice, this means start-ups using Easy13485 are typically audit-ready in ~5 months, depending primarily on NB scheduling and product-specific factors.
Investor view:
Instead of tying up capital for a year or more, the Easy13485 model allows ISO 13485 certification in about 5 months, bringing regulatory milestones in line with funding tranches and enabling an earlier focus on market readiness.
The timeline to CE marking depends heavily on the risk class of the medical device and the chosen regulatory pathway. For Class I devices, CE marking can be achieved relatively quickly because it is based on self-declaration—provided the technical documentation and risk management files are in place. For Class IIa and higher, certification involves a Notified Body (NB), and the timeline usually extends to 9–18 months, depending on NB capacity, the completeness of documentation, and whether external testing is required. The fastest routes are characterized by early preparation of technical documentation, strong project management, and limiting delays in NB scheduling.
With Easy13485:
The process is accelerated because the QMS is operational within 1–2 weeks, not months. From that moment, the start-up can immediately begin drafting every required document of the technical documentation using pre-structured templates. This means progress toward CE marking starts almost immediately, rather than after a long setup phase.
Easy13485 supports a wide range of device types:
Currently, Easy13485 does not support out-of-the-box:
Investor view:
Instead of waiting months to even begin documentation, a start-up using Easy13485 is productive from week one, significantly reducing time to CE marking. The exact duration still depends on device class and NB involvement, but Easy13485 removes the typical 6–8 months of early inefficiency, aligning regulatory milestones more tightly with funding timelines.
The most common reasons QMS certification projects take much longer than expected are:
With Easy13485:
Delays are minimized because the system already covers all areas the NB may audit, even those not typically expected from a start-up in early audits. Easy13485 is continuously updated based on the latest NB audit focus points, so every participant benefits from the experiences of others. For example, process risk assessment and process software validation—often neglected by first-time start-ups—are already built into the system. That means fewer nonconformities at Stage 1, smoother Stage 2, and fewer surprises in repeat audits.
Investor view:
Where conventional projects often face 9–12 months with unpredictable extensions, Easy13485 creates a much more predictable ~5-month timeline, with lower risk of follow-up demands from the NB. This predictability is critical for aligning certification milestones with investment rounds and go-to-market planning.
For most start-ups, MDR certification is anything but predictable. Each product class brings its own set of requirements, and many first-time founders underestimate the scope beyond ISO 13485. Delays often come from gaps in risk management files, usability documentation, or cybersecurity controls. In addition, Notified Bodies apply their own interpretations and audit priorities, which can shift over time. The result: unpredictable timelines, escalating costs, and milestones that slip out of sync with funding plans.
With Easy13485:
Predictability is built into the system. Easy13485 doesn’t just cover ISO 13485 but also integrates all the relevant product-specific standards for the supported device types—such as risk management (ISO 14971), usability (IEC 62366), cybersecurity (IEC 81001-5-1
1 and IT operation (ISO/IEC 27001), software development (IEC 62304), and SaMD requirements (IEC 82304-1). In addition, MDR Article 10 requirements for manufacturers are fully embedded.
The start-up is guided step by step through all workstreams with stage-gate reviews. These checkpoints highlight deviations early and prevent costly surprises at the NB stage. The entire process is modeled on IPP’s experience in managing mission-critical large projects, ensuring the same discipline around planning, reporting, and meeting commitments on time and budget.
Investor view:
Instead of a vague 12–18 month journey, Easy13485 turns MDR certification into a structured, milestone-driven process. Investors gain visibility into progress, confidence that hidden standards won’t surface as last-minute blockers, and assurance that regulatory milestones align with financial planning. In short: MDR certification becomes a predictable track rather than an open-ended risk.
Even with a disciplined internal project, MDR timelines are not entirely within a start-up’s control. Investors should be aware of external variables that can significantly affect duration and cost:
With Easy13485:
While no system can remove all external dependencies, Easy13485 reduces their impact:
Investor view:
The key external variables—NB scheduling and external testing—remain outside direct control. But Easy13485 ensures that internal readiness is never the bottleneck. This shifts the MDR process from an open-ended risk to a largely predictable timeline, with external variables clearly identified and managed early
Certification and compliance costs can vary widely. This section clarifies expected spend, ongoing burn, and how Easy13485 helps control both.
Yes, you can do it the conventional way—and many do—spending €50–100k on consulting, manual customization, and multiple rework loops. Others try to skip consulting: either founders get pulled off product to build paperwork (burning runway on non-core work) or they underbuild the system and carry a substantial audit risk that can blow your investment in the wind. If you want speed, reliability, and cost control, Easy13485 is the better path: ~€13k for TechDoc + full-service clinical evaluation, then €603/month to keep the QMS current (monitoring MDR/ISO changes, updates, training evidence). Plug-and-play templates, the Academy, and AI support keep teams productive while generating audit-grade records in flow. Result: faster CE self-declaration for Class I, predictable spend, and founders staying focused on building the product—not on rebuilding compliance.
Investor takeaway: Class I with Easy13485 ≈ €13k + €603/month vs. €50–100k conventional—and materially lower execution risk.
Yes, you can follow the conventional route—and many start-ups do—burning hundreds of thousands on consultants or even building a dedicated in-house QM team. In extreme cases, costs rise close to €1 million, especially if consultants stay deeply engaged over several years or if the team tries to brute-force every process internally. And the risk doesn’t stop there: every Notified Body surveillance audit (every 2 years) has the potential to raise the bar, pushing the company to spend even more to “keep up.” This creates a recurring, unpredictable cost block that keeps eating into capital.
With Easy13485, the picture changes. A Class IIa QMS certification requires about €15,000 in services plus NB fees (€8–20k typical). Because the backbone is already compliant, NB corrections are minimized, and internal audits close gaps before submission. Ongoing compliance is handled via the QMS-as-a-Service model at €603/month, ensuring that regulatory changes are integrated continuously instead of in costly rebuilds.
Investor takeaway: Easy13485 keeps Class IIa certification predictable (~€15k + NB) versus potentially €500k–1M with traditional models. More importantly, it prevents the ongoing “audit creep” that can turn compliance into a permanent cost sink.
Yes, you can ask around and get the usual vague answers: “It depends.” But investors need real numbers. For ISO 13485 certification of Class IIa devices, Notified Body fees are fixed and typically fall between €8,000 and €20,000, depending on device complexity and NB capacity. The real hidden risk lies elsewhere: nonconformities (NCs). Every NC flagged by the NB can trigger extra audit time, consulting hours, and additional submissions – quickly turning a fixed NB fee into a cost spiral.
This is where Easy13485 changes the game. Because the QMS backbone is structured and continuously updated, NCs remain predictably low. More importantly, Easy13485 covers all NCs that fall within the QMS framework at no additional cost. That means investors don’t face unexpected invoices or a creeping cost curve when the NB highlights issues.
Investor takeaway: NB fees themselves are fixed, but with Easy13485 the expensive variable (nonconformities) is neutralized. Predictable NB spend, no runaway bills, and an audit process that stays under control
Yes, you can follow the traditional route—outsourcing the full technical documentation and every supporting activity to consultants—and spend €100,000 to €400,000. That covers 200+ documents, endless review cycles, and every external correction charged at premium rates. On top of this, external testing costs vary depending on the product: EMC tests, penetration tests, material property evaluations, and reuse validations can each add significant amounts. In this model, costs grow without control, and investors face a serious risk that capital drains into compliance instead of innovation.
Easy13485 works differently. The system enables the start-up to do most of the work themselves, supported by structured templates, the Academy, and AI assistance. The team chooses an approach that fits its own risk evaluation, while Easy13485 provides guidance and reviews for about €20,000. Additional services are available if more direct support is required, but the core remains lean. This hybrid model means documentation is comprehensive yet capital-efficient.
Investor takeaway: Instead of €100–400k for a full outsourced TechDoc, Easy13485 lets start-ups reach MDR conformity for ~€20k guidance + NB + testing, while keeping founders focused on product and market—not drowning in consulting invoices.
es, the conventional way is to hire or allocate a dedicated Quality Management Representative (QMR). Industry standard: at least 50% of a QMR’s time is consumed just by groundwork – monitoring standards, updating procedures, collecting signatures, and maintaining training logs. That’s roughly €3,500/month in personnel cost before even considering external consultants. And when updates pile up or audits reveal gaps, the bills climb even higher.
Easy13485 makes that unnecessary. Compliance is delivered as a service, for €603/month (≈ mini-job equivalent). This fee covers central monitoring of MDR and ISO updates, immediate integration into the system, and continuous staff training through the Academy. Nonconformities within the QMS are covered at no extra cost. Instead of half a QMR salary plus consultants, investors get a predictable, lean cost structure that keeps the system continuously audit-ready.
Investor takeaway: With Easy13485, ongoing compliance drops from a €3,500+ monthly personnel burden to €603/month all-in, while reducing audit risk and preserving focus on product and market entry.
Strong regulatory execution creates cleaner data rooms and clearer KPIs. This section covers what investors actually see in diligence and how Easy13485 ensures audit readiness is visible early.
When you as investor conduct regulatory due diligence in MedTech, you are not only looking for compliance “on paper,” but for evidence of a functioning system that reduces the risk of delays, recalls, or certification failures. Typical expectations include:
With Easy13485:
The due diligence experience looks very different:
Investor takeaway:
Instead of scattered files and consultant-driven workarounds, a start-up running on Easy13485 can present a live, audit-ready QMS with structured documentation. For investors, this means clearer visibility, faster diligence, and lower execution risk
Regulatory KPIs help you as VC to track whether a MedTech start-up is truly on course for MDR and ISO 13485 compliance. Unlike financial KPIs, these are about execution discipline, risk reduction, and audit readiness. The most relevant ones are:
With Easy13485:
The system makes these KPIs visible and measurable in real time:
Investor takeaway:
Instead of anecdotal updates, Easy13485 delivers hard regulatory KPIs: training completion, audit closure rates, documentation progress, and CAPA performance. These allow boards and VCs to monitor compliance maturity just like financial metrics—turning regulatory risk into a transparent, manageable variable.
You as VC don’t just want to hear that a start-up “is preparing for audits”—you want tangible proof that the company can pass one. Before CE marking, the strongest signals of audit readiness are:
These elements provide objective evidence that compliance is not theoretical, but operational.
With Easy13485:
Start-ups in the Easy13485 Makerspace can show investors three concrete layers of proof:
Regulatory execution risk in MedTech start-ups comes from three main factors:
For investors, these gaps translate into delays, wasted capital, and valuation risk when regulatory milestones are missed.
How Easy13485 mitigates these risks:
Investor takeaway:
Easy13485 transforms regulatory execution from a high-risk, unpredictable factor into a managed baseline. Investors gain assurance that start-ups won’t fail on compliance, that milestones will be met on time and budget, and that regulatory maturity is visible in due diligence. This reduces execution risk, protects capital, and supports faster valuation growth.
After certification, compliance must be maintained without slowing growth. Here we address portfolio scaling, ongoing system management, and the valuation impact of regulatory readiness.
Traditionally, every MedTech start-up sets up its own ISO 13485 QMS. This makes it very hard to transfer knowledge or resources from one company to another. Each system has its own structure, terminology, and documentation flow – which creates inefficiencies, higher consulting costs, and very limited synergies at portfolio level.
How Easy13485 solves this:
Shared framework, independent tenants: Each start-up gets its own QMS environment, but all rely on the same Easy13485 backbone. This preserves independence while ensuring consistency.
No “translation problems”: Because the same templates, processes, and Academy trainings are used, teams can easily understand each other’s documentation. Everyone “speaks the same regulatory language.”
Cross-learning effect: Nonconformities identified in one company are corrected in the framework for all – so the next start-up doesn’t repeat the same mistake.
Investor advantage: Instead of reviewing a different QMS philosophy in every portfolio company, investors get comparable KPIs, audit trails, and documentation structures.
Investor takeaway:
Without Easy13485, portfolio companies work in silos, and compliance knowledge is not transferable. With Easy13485, each start-up keeps its independence but benefits from a common compliance backbone – lowering costs, reducing regulatory risk, and creating true portfolio synergies.
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General perspective:
For MedTech start-ups, valuation is closely tied to how investors perceive risk and time-to-market. A brilliant product concept has little value if the regulatory pathway is unclear or unpredictable. Regulatory readiness directly impacts valuation in three ways:
De-risking capital
Investors discount valuations heavily when regulatory uncertainty exists.
Start-ups without an audit-ready QMS or technical documentation often see slower fundraising or worse terms.
Time-to-market predictability
Every month lost in CE marking delays revenue, reimbursement, and partnership opportunities.
Start-ups that can prove a clear, predictable compliance timeline secure higher valuations because they show that capital will convert to market entry faster.
Investor confidence signals
Evidence of internal audits, training records, CAPA management, and structured technical documentation are strong diligence signals.
These demonstrate organizational maturity, which boosts investor trust and reduces perceived execution risk.
How Easy13485 changes the equation:
Shorter certification timelines: By compressing QMS certification to ~5 months and guiding start-ups through MDR requirements, Easy13485 helps companies reach diligence-grade status faster.
Lower burn rate: Instead of sinking 50–100k€+ into fragmented consulting, Easy13485 offers a predictable cost model (13k€–20k€ for typical pathways), keeping more capital available for growth activities.
Comparable KPIs across portfolio companies: Investors see standardized training evidence, QMS progress, audit trails, and technical documentation — making it easier to benchmark and value companies consistently.
Reduced reclassification shock: Because higher-class requirements are embedded early, start-ups avoid expensive pivots if a device is up-classified
After a start-up achieves CE marking, the regulatory work is not finished — it shifts into post-market obligations: surveillance, vigilance reporting, continuous training, and regular QMS updates. Many start-ups stumble at this stage because they treat CE marking as the end point, while in reality it is the beginning of commercialization under regulatory oversight. If these processes are not embedded, sales partners, distributors, and hospital buyers will hesitate because they don’t see long-term compliance assurance.
How Easy13485 accelerates commercialization:
Post-Market Surveillance (PMS) built in
Easy13485 includes ready-to-use PMS and vigilance processes. This means from the first customer interaction, evidence of complaints, feedback, and corrective actions is already structured.
Hospitals and insurers see audit-grade reporting instead of improvised tracking.
Training & onboarding at scale
With the Easy13485 Academy, new hires, distributors, and sales partners can be trained instantly with role-based modules.
This reduces onboarding time and ensures consistent compliance culture across expanding teams.
Continuous compliance updates
Easy13485 centrally monitors changes in MDR and ISO standards, then updates processes and templates across all customers.
Start-ups don’t lose momentum or risk nonconformities when regulations evolve.
Audit-ready commercialization
Internal audits and CAPA management continue post-CE, proving to partners and investors that the company remains inspection-ready.
This credibility accelerates contract negotiations with hospitals, insurers, and distributors.
Investor confidence in scaling
The fact that Easy13485 provides a live, diligence-grade system post-marketing means investors can see regulatory maturity even as sales scale.
This de-risks follow-on funding and supports higher valuations.
Investor takeaway:
With Easy13485, commercialization doesn’t stall after CE marking — it accelerates. By embedding PMS, vigilance, training, and compliance updates directly into the QMS-as-a-Service, start-ups can focus on sales, partnerships, and growth, while investors gain confidence that compliance will not collapse under scale.
Regulatory requirements evolve. From MDR pitfalls to IVDR expansion, this section explains how Easy13485 mitigates risk, prevents audit failures, and prepares teams for future compliance demands.
For MedTech start-ups, regulatory risk under MDR can cut both ways:
The reality is: no start-up will win because of regulatory work alone—but many will fail because of regulatory gaps.
With Easy13485:
The system is designed to eliminate almost all regulatory execution risk. It embeds the essentials of MDR and ISO 13485 directly into workflows, covering QMS, risk management, usability, cybersecurity, and product-specific requirements. Updates are integrated continuously, and start-ups benefit from audit learnings across all Easy13485 users. The only requirement: the team must consistently follow the system.
Investor view:
Easy13485 ensures that regulatory becomes a managed baseline, not a risk factor. Investors gain confidence that compliance won’t derail product timelines or consume runaway budgets. In practice, this means regulatory moves from an existential risk to a predictable cost of doing business—while founders stay focused on product and growth.
The most common source of compliance failures is a lack of regulatory understanding among founders. Many start-ups either under-resource compliance (thinking it’s just paperwork) or over-resource it (burning capital on documentation far beyond what’s required). Both paths create risk: one leads to audit findings and delays, the other to wasted runway. To avoid this, investors need confidence that start-ups are trained, structured, and supported by a reliable partner.
The Easy13485 approach:
Easy13485 mitigates these risks in three ways:
Investor takeaway:
Avoiding compliance failures is not about hiring more consultants; it’s about making sure founders understand their obligations, have systematic training, and operate within a reliable framework. Easy13485 delivers exactly that: mandatory Article 10 onboarding, access to 150+ Academy trainings, and a structured compliance service that reduces execution risk and protects investor capital. You are welcome to register yourself for free. Course: Startups & MDR: Your 16 Legal Duties | IPP Academy
Regulatory execution risk in MedTech start-ups comes from three main factors:
For investors, these gaps translate into delays, wasted capital, and valuation risk when regulatory milestones are missed.
How Easy13485 mitigates these risks:
Investor takeaway:
Easy13485 transforms regulatory execution from a high-risk, unpredictable factor into a managed baseline. Investors gain assurance that start-ups won’t fail on compliance, that milestones will be met on time and budget, and that regulatory maturity is visible in due diligence. This reduces execution risk, protects capital, and supports faster valuation growth.
The most frequent audit failures in MedTech are fairly consistent across start-ups:
These failures occur because teams either don’t know the expectations, or they underestimate the detail Notified Bodies look for.
How Easy13485 prevents them:
Investor takeaway:
Instead of firefighting nonconformities at audit time, Easy13485 ensures start-ups build audit-grade evidence continuously. This reduces the likelihood of costly findings, keeps timelines on track, and protects investor capital from regulatory derailment
General perspective:
The In Vitro Diagnostic Regulation (IVDR) places much higher demands on diagnostics start-ups than the old IVDD — including stronger evidence requirements, more Notified Body oversight, and continuous post-market obligations. For many diagnostics devices, this means more time, higher costs, and more external dependencies.
With Easy13485:
MDR-aligned QMS as a foundation: Since IVDR requirements are very close to MDR, the Easy13485 QMS provides a strong baseline (risk management, PMS, vigilance, training, etc.).
Not out-of-the-box: IVDR-specific processes (performance evaluation, analytical and clinical data structures) are not standard in Easy13485.
Tailored solutions: For diagnostics start-ups, we adapt Easy13485 with IVDR-specific templates and workflows, ensuring that each company has the structures it needs for its exact classification.
Scalable approach: This lets diagnostics start-ups benefit from the shared Easy13485 backbone while receiving custom IVDR add-ons that fit their product and risk profile.
Investor takeaway:
IVDR raises the compliance bar for diagnostics significantly. Easy13485 cannot deliver IVDR compliance “one-size-fits-all,” but it offers a ready MDR-level foundation plus tailored IVDR adaptation. This combination keeps start-ups faster, leaner, and investor-ready, while still meeting the much stricter IVDR demands.