Expand Your Medical Devices & Diagnostics to EU & USA
Full-service market entry for SEA manufacturers: From CE/FDA compliance to Amazon Top Seller status. We handle regulatory, branding, e-commerce, distribution, and logistics so you can scale globally.
The Challenge of International Expansion
SEA manufacturers face significant hurdles when expanding to EU and USA markets. We solve all of them.
Complex CE & FDA Regulations
Navigating EU MDR/IVDR and FDA 510(k) requirements is overwhelming and time-consuming
Language & Cultural Barriers
Product documentation, marketing, and customer support require native-level fluency
Distribution Network Gap
Building relationships with DACH/USA distributors, pharmacies, and retailers from scratch
Amazon Marketplace Complexity
Optimizing listings, managing FBA logistics, and competing effectively on Amazon EU/USA
Market & Cultural Differences
Understanding local consumer behavior, pricing expectations, and competitive landscape
Logistics & Fulfillment Challenges
Setting up EU/US warehousing, managing customs, and ensuring reliable delivery networks
Complete Market Entry Services
End-to-end support from regulatory compliance to revenue generation. We handle everything.
Regulatory Compliance
Market Research & Strategy
Branding & Design
E-Commerce & Digital
Distribution & B2B Sales
Logistics & Operations
Growth & Scale
Our Proven 4-Step Process
From compliance to revenue in 4-6 months. Clear milestones, transparent timelines, measurable results.
Audit & Assessment
We analyze your products, documentation, and business goals to create a customized expansion strategy.
- ✓Product portfolio review
- ✓Regulatory gap analysis
- ✓Market opportunity assessment
- ✓Budget & timeline planning
Regulatory Compliance
CE marking, FDA registration, and all necessary certifications to legally sell in EU/USA markets.
- ✓Technical file preparation
- ✓Notified Body submission
- ✓FDA registration & listing
- ✓Label & IFU translation
Market Launch
Brand development, e-commerce setup, distribution partnerships, and logistics infrastructure.
- ✓Brand & packaging design
- ✓Amazon/Shopify store setup
- ✓Distributor onboarding
- ✓Warehouse & fulfillment setup
Scale & Growth
Continuous optimization, expansion to new markets, and revenue growth through data-driven strategies.
- ✓Performance monitoring & reporting
- ✓Marketing campaign optimization
- ✓New market expansion planning
- ✓Product line extension support
Audit & Assessment
We analyze your products, documentation, and business goals to create a customized expansion strategy.
- ✓Product portfolio review
- ✓Regulatory gap analysis
- ✓Market opportunity assessment
- ✓Budget & timeline planning
Regulatory Compliance
CE marking, FDA registration, and all necessary certifications to legally sell in EU/USA markets.
- ✓Technical file preparation
- ✓Notified Body submission
- ✓FDA registration & listing
- ✓Label & IFU translation
Market Launch
Brand development, e-commerce setup, distribution partnerships, and logistics infrastructure.
- ✓Brand & packaging design
- ✓Amazon/Shopify store setup
- ✓Distributor onboarding
- ✓Warehouse & fulfillment setup
Scale & Growth
Continuous optimization, expansion to new markets, and revenue growth through data-driven strategies.
- ✓Performance monitoring & reporting
- ✓Marketing campaign optimization
- ✓New market expansion planning
- ✓Product line extension support
Why Bormann Bioscience?
We're not just consultants – we're operators. We run DrinkCheck, parahealth, Dr. Weber, and HaseMed across Amazon EU/USA and 10+ European marketplaces — directly and with partners.
Proven Track Record
50+ successful product launches across EU and USA markets with documented revenue growth.
Deep Market Expertise
We operate our own brands (DrinkCheck, parahealth, Dr. Weber, HaseMed) – we know what works.
Done-For-You Model
Not consultants giving advice – we execute everything from A to Z while you focus on production.
Speed & Clear Processes
4-6 month launch timelines with transparent milestones. No delays, no surprises.
Scalable Revenue Models
From fixed-fee packages to revenue-share partnerships – flexible commercial terms.
Multilingual Team
Native speakers in 14 languages including German, English, French, Spanish, and Chinese.
Flexible Pricing Packages
Choose the model that fits your business stage – from fixed-fee compliance to full revenue-share partnerships.
Starter
Compliance Ready
Essential regulatory compliance to make your products EU/USA market-ready.
Launch
Go-to-Market
Full market entry package: compliance, branding, and e-commerce setup.
Scale
Full Service
Done-for-you market expansion with ongoing management and growth optimization.
Exclusive
Distribution Partnership
We become your exclusive EU/USA distributor with full end-to-end responsibility.
Not sure which package fits?
Book a free 30-minute consultation. We'll assess your products, goals, and budget to recommend the optimal market entry strategy.
Ready to Expand to EU & USA?
Book a free 30-minute consultation with our expansion team. We'll assess your products, discuss regulatory requirements, and outline a clear roadmap to launch in EU/USA markets.
Enter EU/USA Markets
Partner with us to bring your products to international markets