Your First EU MDR Certification
From Austrian MedTech startup to CE certification - with funding-optimized planning
You have the innovation. You have the funding. Now you need the EU MDR certification. We guide Austrian startups through their first certification.
Every MedTech Startup Faces These Challenges
The path to MDR certification is complex - but it does not have to be overwhelming. Understanding your challenges is the first step.
Regulatory is Uncharted Territory
Your founders are experts in technology, medicine, or business - not in EU MDR. The 200+ pages of regulation feel like learning a new language while building a rocket.
Deploy Funding Wisely
FFG, aws, or private investors gave you capital with expectations. Every Euro spent on regulatory needs to deliver maximum value toward your certification goal.
Time is Running
Your runway is limited. Investors expect milestones. Competitors are moving. Every month of delay in certification is a month of lost market opportunity.
"90% of MedTech startups fail not because of their technology, but because they underestimate the regulatory pathway. They start too late, budget too little, and lack the expertise to navigate MDR efficiently. This is entirely preventable."
The Six Hurdles Every Startup Faces
These challenges stop most startups. Recognizing them is the first step to overcoming them.
Regulatory Know-how Missing
Your team builds great products but has never navigated EU MDR. The learning curve is steep and expensive when done wrong.
Budget is Limited
Funding rounds set expectations. You cannot afford to waste money on consultants who do not deliver or approaches that do not work.
Time Pressure
Investors want milestones. Competitors are moving. Every month of delay is market opportunity lost and runway consumed.
Clinical Evidence Unclear
Do you need clinical investigations? What about equivalent devices? The clinical evaluation requirements seem designed to confuse.
QMS Setup Overwhelming
ISO 13485 requires 20+ procedures, forms, and records. Building from scratch while running a startup feels impossible.
Notified Body Roulette
Which Notified Body? What timeline? What do they really want to see? The uncertainty makes planning nearly impossible.
Welcome to Your Regulatory Team on Demand
You do not need to hire a full regulatory department. You need experienced partners who know the path and can guide you through it efficiently.
Complete Build from Zero
We help you build your entire regulatory foundation: QMS, technical documentation, clinical evaluation - everything you need for certification.
Funding-Optimized Planning
We structure projects to maximize FFG, aws, and regional funding. Your investor money goes further with proper planning.
Know-How Transfer
We do not just do it for you - we teach you. Your team builds internal competence while we work together.
Book a Strategy Call
Find out how we can help you achieve EU MDR certification - efficiently and funding-optimized.
- Assess your regulatory pathway
- Identify funding opportunities
- Get a tailored project timeline
No commitment. 30-minute call to assess your needs.
Why Startups Choose Us
We understand startup constraints. Our approach is designed for companies with limited resources and big ambitions.
Structured Process
Clear phases, defined milestones, predictable outcomes. You always know where you are and what comes next.
Budget Transparency
Fixed-price packages where possible. Clear cost estimates always. No surprise invoices that blow your budget.
Learning by Doing
Your team learns regulatory while we work together. Build internal competence that lasts beyond our engagement.
Faster Through Experience
We have done this many times. You benefit from lessons learned, templates proven, and relationships established.
Your Path to MDR Certification
A typical Class IIa certification takes 18-24 months. Here is how we structure the journey for maximum efficiency.
Foundation & Strategy
- Device classification assessment
- Regulatory pathway definition
- Intended Purpose definition
- Project plan & budget
Build Documentation
- Technical documentation structure
- Risk management (ISO 14971)
- GSPR checklist
- Labeling & IFU development
Implement QMS
- ISO 13485 compliant QMS
- Document control system
- CAPA procedures
- Internal audit preparation
Testing & Clinical Evidence
- Verification & validation planning
- Biocompatibility testing
- Clinical evaluation report
- PMCF plan (if required)
Notified Body Process
- NB selection & application
- Documentation submission
- Question response management
- Audit preparation & support
Market Launch
- CE certificate issuance
- EU Declaration of Conformity
- EUDAMED registration
- Post-market surveillance setup
Timelines vary based on device classification, complexity, and your team's availability. Class I devices typically complete faster; Class IIb/III require more time.
Maximize Your Public Funding
Austrian startups have access to excellent funding programs. We help you structure your regulatory project to qualify for maximum support.
FFG Programs
Basisprogramm, Bridge, and other FFG programs can fund regulatory development. We help structure eligible work packages.
aws Funding
PreSeed, Seed Financing, and aws grants support MedTech development including regulatory pathway work.
Regional Programs
Vienna, Styria, Upper Austria, and other regions offer additional MedTech and innovation funding.
Typical Result: 25-70% of regulatory costs covered through optimized funding structure. We support with applications and help finding eligible scopes.
Funding-Eligible Activities
- QMS development and implementation
- Risk management activities
- Clinical evaluation development and clinical studies
- Verification & validation testing
- Biocompatibility testing
- Technical documentation
Common Startup Pitfalls (And How to Avoid Them)
We have seen these mistakes repeatedly. Learning from others' experiences saves you time and money.
Starting Regulatory Too Late
"We will figure out regulatory after we finish the product." This leads to costly redesigns, missed investor milestones, and extended timelines.
Design for Compliance from Day One
Start regulatory planning when you define your product concept. Building compliance into design saves 6-12 months vs. retrofitting.
Underestimating Budget & Timeline
"We budgeted EUR 50,000 and 6 months for certification." For Class IIa, this is typically 4x too little money and 3x too short.
Plan with Realistic Numbers
Class IIa typically requires EUR 200,000-400,000 and 18-24 months. We provide accurate estimates upfront so you can plan properly.
Hiring Too Junior or Too Expensive
Either hiring a junior RA coordinator who lacks experience, or paying EUR 2,000/day for big consultancy overhead that does not fit startup budgets.
Flexible Expert Support
Get senior expertise when you need it, without full-time overhead or big consultancy markups. Scale support up or down as your needs change.
Building QMS That Does Not Fit
Using large company templates or generic QMS software that creates more bureaucracy than a 10-person startup can maintain.
Right-Sized QMS
Build a lean QMS that meets ISO 13485 requirements without unnecessary complexity. You can scale it as you grow.
Ignoring Clinical Strategy
"We will figure out clinical evidence later." This often leads to discovering you need expensive clinical studies when you thought you did not.
Early Clinical Planning
Define your clinical evaluation strategy early. Understand whether equivalence works for you or if you need clinical data before committing resources.
What We Do Not Do
Honesty about our boundaries helps you make the right choice. We prefer to be upfront about what we will not promise.
No Miracle Promises
We will not promise "6-month certification" or "guaranteed approval." MDR is complex, and realistic timelines matter more than false hope. If someone promises miracles, be skeptical.
No Ghostwriting Without Team
We do not create documentation in isolation. Your team must be involved - this is your product, your company, and you need to understand and own your regulatory system.
No Taking Over The Whole Process
We will support and guide you throughout the whole process, but you cannot simply handover a CE certification. This process will be one of your key assets and your competitive moat; use it wisely.
No Support Without Budget
We require minimum project budgets of EUR 200,000+ for Class IIa certification. If your total regulatory budget is under this, we are likely not the right fit - and we will tell you so honestly.
What Austrian Startups Say
Real feedback from founders who have been through the MDR certification journey with us.
"Zechmeister Strategic Solutions helped us bring clarity to a confusing certification landscape. They laid out the viable pathways, gave us realistic cost and timeline ranges, and explained everything in a way our whole team could act on. What we valued most was the pragmatic mindset and the ability to explore non-obvious routes that still made regulatory sense."
"For our novel elderly-care device, Zechmeister Strategic Solutions built and drove a clear roadmap to CE certification. Even with a lean team and tight resources, they kept the work moving, prioritized the right evidence, and helped us complete the technical documentation on schedule. The combination of speed and precision made a real difference."
"Zechmeister Strategic Solutions supported us as internal auditors and brought a rare mix of rigor and practicality. They identified meaningful improvement opportunities without disrupting what already worked, and helped us translate ISO 13485 requirements into lean processes that actually strengthen operations. The audit felt productive, not painful."
"Zechmeister Strategic Solutions streamlined our certification approach and gave us a concrete, actionable plan. Their regulatory strategy helped us choose a Class I pathway, saving significant time to market and avoiding unnecessary workload. They also helped establish the foundational documentation and a working QMS, which improved our readiness and execution speed."
Frequently Asked Questions
Answers to the questions Austrian startups ask most often about MDR certification.
For a Class IIa device, you should plan with EUR 200,000-400,000 total budget over 18-24 months. This includes regulatory consulting, QMS setup, testing, and Notified Body fees. We help you optimize this with available funding programs. Class I sterile/measuring devices typically cost EUR 100,000-200,000. Class IIb and III require significantly more.
Typically 18-24 months for Class IIa devices, 12-18 months for Class I sterile/measuring. This includes building your QMS from scratch, completing all technical documentation, and the Notified Body review process. The timeline depends heavily on your team's availability and how quickly you can complete product verification and validation testing.
Yes, and you should. Starting QMS development and regulatory strategy early saves time and prevents costly redesigns. We can begin once you have a clear product concept and intended use. Building compliance into your design from day one is far more efficient than retrofitting later.
FFG (Basisprogramm, Bridge), aws (Seed Financing, PreSeed), and regional funding programs can cover 25-70% of eligible costs. We help structure your project phases to maximize funding utilization. Regulatory work including QMS development, risk management, and clinical evaluation are typically fundable activities.
For many well-established devices, a literature-based approach with equivalence is possible. For novel devices or higher risk classes, clinical investigation may be required.
You need at least one Person Responsible for Regulatory Compliance (PRRC) - which can be external initially. We can act as your outsourced regulatory team until you build internal capabilities. Most startups work successfully with our support and 0.5-1 FTE internal dedicated to quality and regulatory activities.
For most startups, partial outsourcing makes sense initially. A senior full-time RA manager costs EUR 80,000-120,000/year including benefits. Our flexible support model costs less while providing senior expertise when you need it. Once you have multiple products or ongoing regulatory maintenance needs, hiring makes more sense.
Underestimating timelines and budgets. Many startups allocate 6 months and EUR 50,000 when they need 18 months and EUR 200,000+. Starting with realistic planning prevents investor disappointment and funding gaps. The second biggest mistake is starting regulatory work too late, after the product design is frozen.
Meet Your Regulatory Expert
Tibor Zechmeister
Founder & Lead Consultant15+ years in MedTech regulatory affairs, from startups to Fortune 500 medical device companies. Certified ISO 13485 Lead Auditor. Former regulatory lead at major Austrian and German medical device manufacturers.
MDR Readiness Guide for Austrian Startups
A practical guide covering the essentials every startup needs to know before beginning their MDR certification journey.
- MDR scope and intended purpose sanity check
- Device classification decision support (incl. software Rule 11)
- Budget planning worksheet
- MDR readiness scorecard and 30 day action plan
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Book Your Free 30-Minute Initial Consultation
No sales pitch, no commitment. Just an honest assessment of your situation, your challenges, and whether we can help. If we are not the right fit, we will tell you and suggest alternatives.
Or email us directly at office@zechmeister-solutions.com