Your Gateway to Europe
From international certification to EU MDR approval
You've already proven your medical device works in the USA, Asia, or other markets. Now you want to enter the European market quickly and efficiently. We are your strategic partner with an established ecosystem of EU experts.
The Reality of EU Market Entry for International Companies
Long Lead Times
Traditional processes take 18-36 months from start to certification.
Certification Costs
Certification costs of EUR 500,000-1,200,000+ strain your budget.
Complex EU Requirements
EU MDR differs fundamentally from FDA, TGA, or other regulations.
Authorized Representative Required
As a non-EU manufacturer, you need a legal representative in Europe.
Unclear Processes
Without established contacts, you navigate in the dark.
Resource Binding
Building internal EU regulatory team ties up resources for years.
You Are Not Alone
EU MDR as Black Box
Many international companies struggle to understand the intricate requirements that differ significantly from FDA or other regulatory frameworks.
Time is Your Biggest Cost Factor
Every month of delay means lost revenue, increased competition, and missed market opportunities in the EUR 150B+ European medical device market.
Universal Challenge
Whether you're coming from the USA, Japan, Australia, or other markets, the challenges of EU market entry are remarkably similar.
"Mistakes in EU market entry can cost companies EUR 100,000+ per month due to delays and a total setback of 12-24 months. The most efficient path is with experienced partners who know the European market inside out."
Welcome to Your Strategic EU Market Entry Partner
Strategic Solutions for MedTech - Your Copilot for the European Market
Strategic Guidance
Clear roadmap from gap analysis to certification with expert navigation at every step
Established Ecosystem
Access to all necessary EU partners through one point of contact - no coordination chaos
Hands-On Co-Creation
No ghostwriting - we work WITH your team to build lasting competence
75%
Up to 75% Faster Market EntryCertification lead time reduced through highest preparation standards
70%
Up to 70% Cost ReductionStrategic partnerships and efficient preparation
Transparent Calculation
Clear timeline and budget planning from day one
EU Market Access Secured
Authorized Representative services included
One Ecosystem. One Point of Contact. Full Control.
Access our established network of EU partners without the coordination headaches
Your Path to EU MDR Certification – Example Timeline
Phase 1: Strategic Assessment
Comprehensive gap analysis of your existing documentation, regulatory status, and market entry strategy. We identify exactly what's needed for EU MDR compliance based on your current approvals (FDA/TGA etc.).
Phase 2: Documentation & QMS Upgrade
Technical documentation preparation and quality management system alignment to EU MDR requirements, building strategically on your existing documentation.
Phase 3: Testing & Clinical Evidence
Biocompatibility testing, clinical evaluation, and any required clinical studies conducted through our established laboratory and clinical partner network.
Phase 4: Notified Body Process
Submission to a suitable Notified Body with support in receiving offers, scope confirmation, and submission support.
Phase 5: Market Entry
CE marking obtained, EUDAMED registration complete, and your product ready for European market launch with full regulatory support.
Traditional Path vs. With Strategic Solutions
| Criteria | Traditional Route | With Strategic Solutions |
|---|---|---|
| Timeline to Certification | 18-36 months | 9-18 months (up to 75% faster) |
| Total certification costs | 500k to 1.2 mio | 150k - 360k (up to 70% savings) |
| NB Offer Time | 6-12 months queue | 1-2 months |
| Partner Coordination | Multiple vendors, your management | Single point of contact |
| Risk of Delays | High - unknown requirements | Low - proven process |
| Documentation Quality | Learning curve with NB | NB-ready from start |
| Authorized Representative | Separate contract needed | Included |
| Approach | Transactional / outsourced | Co-creation with knowledge transfer |
What We Don't Do
We believe in setting clear expectations from the start
No Ghostwriting
We don't write your documentation for you and disappear. We work collaboratively with your team to build internal competence and ensure sustainable compliance.
No One-Size-Fits-All
Every device and company is different. We provide honest assessments and customized strategies rather than unrealistic guarantees or cookie-cutter solutions.
No Research Projects
We focus on companies with proven products and existing certifications. If you're still in R&D phase without regulatory clearance, we can recommend appropriate partners.
No Large Corporation Bureaucracy
We're a focused boutique firm. You work directly with senior experts, not junior consultants following scripts. Fast decisions, direct communication.
What Industry Experts Say
"Zechmeister Strategic Solutions brings a rare combination of Notified Body mindset and manufacturer pragmatism. Their Annex II/III structure, GSPR evidence mapping, and clean traceability make technical documentation genuinely reviewer-ready and reduce iterative question cycles."
"EU MDR success is won or lost in the claim-to-evidence chain. Zechmeister Strategic Solutions aligns intended use, labeling, risk management (ISO 14971), and clinical evaluation so the file is defensible, consistent, and built for audit scrutiny from day one."
"For international manufacturers, EU market entry fails when workstreams stay siloed. Zechmeister Strategic Solutions runs QMS (ISO 13485), clinical, testing, AR, and partner coordination as one controlled program, which is exactly how timelines and budgets stay predictable."
Frequently Asked Questions
With our established ecosystem, Notified Body offer times are reduced from 6-12 months to just 1-2 months. Traditional processes take 18-36 months from start to certification. The exact timeline depends on device classification and existing documentation quality.
Not necessarily. Existing clinical data from e.g. FDA or TGA submissions can often be leveraged. We conduct a gap analysis to identify what additional clinical evidence may be required under EU MDR requirements, often saving significant time and cost.
An Authorized Representative (AR) is legally required for non-EU manufacturers placing medical devices on the European market. The AR acts as your legal representative in the EU, handling regulatory correspondence and maintaining technical documentation accessibility. Our AR services are included in our partnership.
Traditional routes can cost EUR 500,000-1,200,000+. Through our strategic partnerships and efficient preparation, costs are typically reduced to EUR 150,000-360,000 – up to 70% savings while maintaining full compliance. We provide transparent cost breakdowns after your initial strategic assessment.
Yes, we specialize in portfolio strategies that maximize efficiency across multiple devices, leveraging shared documentation, testing, and Notified Body relationships for significant economies of scale.
MDD certificates have expired or are expiring. We help transition your device to EU MDR compliance efficiently, building on your existing documentation while addressing new requirements systematically.
We offer transparent, retainer-based models and pricing with no hidden fees. After the initial strategic assessment, you receive a detailed cost breakdown for the entire certification journey. We believe in predictable budgets for predictable outcomes.
Our founder has worked as a Lead Auditor at a Notified Body, giving us unique insight into what NB auditors look for. We prepare documentation that meets expectations from day one, reducing review cycles and delays.
Meet Your EU MDR Navigator
Tibor Zechmeister
Founder & Lead Regulatory Expert- Lead Auditor at EU Notified Body
- 15+ years Medical Device Regulatory Affairs experience
- 50+ successful EU MDR certifications guided
- Former Founder and Head of Regulatory at international MedTech company
- State accredited MDR - QMS expertise
"Our team has seen the EU MDR certification process from both sides - as Notified Body auditors and as manufacturers. This dual perspective allows us to prepare your documentation exactly the way auditors expect it, eliminating costly revision cycles."
Senior Technical Documentation Expert
MDR Technical Documentation Lead- Annex II/III technical file creation and remediation
- GSPR checklist and evidence mapping (end-to-end traceability)
- IFU, labeling, UDI, and claims alignment with clinical evidence
- RMF integration (ISO 14971) and benefit-risk narrative
- PMS/PMCF documentation packaging for efficient NB review
"Great technical files are not longer. They are structured for the reviewer, fully traceable, and defensible under every essential requirement."
Senior QMS Expert
MDR Quality Management Lead- ISO 13485 QMS build or upgrade aligned with MDR requirements
- Process mapping, SOP architecture, and controlled templates
- Supplier controls and critical supplier qualification
- Internal audits, management review, and CAPA closure support
- NB audit preparation and finding response strategy
"Audit success is not the audit day. It is the system design that makes compliance the default, not the exception."
Senior Biocompatibility Expert
MDR Biocompatibility Lead- Biological Evaluation Plan (BEP) and MDR-ready test strategy
- ISO 10993 gap assessment based on contact type and duration
- Toxicological risk assessment and extractables/leachables rationale
- Lab coordination, sample definition, and failure avoidance review
- Biological Evaluation Report (BER) aligned with clinical evaluation
"Biocompatibility is not a test list. It is a scientific justification that proves patient safety with the minimum necessary testing."
Senior Clinical Evaluation Expert
MDR Clinical Evaluation Lead- Clinical evaluation strategy (literature, equivalence, PMCF, study)
- CER writing under MDR with clear claim-evidence linkage
- Literature review methodology, appraisal, and data extraction
- SSCP support (where applicable) and clinical benefits narrative
- PMCF plan and evaluation report aligned with PMS system
"A strong CER reads like a decision file. Every claim is linked to evidence, every gap has a plan, and every risk has a clinical rationale."
Regulatory Project Coordinator
Market Entry Program Lead- Single point of contact for customer, experts, and network partners
- Workstream planning across TD, QMS, testing, clinical, and AR
- Milestone tracking, meeting cadence, and action management
- Risk register and rapid escalation for blockers and scope changes
- Submission readiness checks and stakeholder alignment to closure
"Speed comes from orchestration. When decisions, documents, and vendors move in one system, certification stops being unpredictable."
EU Market Entry Guide for International Companies
For medical device manufacturers already approved in any non-EU market who want to transfer into EU MDR.
- 25-point EU MDR transfer readiness checklist (with scoring + traffic light)
- Evidence guide: what “YES” needs to look like (typical artifacts)
- Overview of the most important topics to deal with when entering the EU market
- Readiness report page: top blockers + first 30-day focus
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