Product development for startups, directly from Vienna
From prototype to certified series product. We make sure your production costs don't spiral out of control and that you hit your time-to-market.
The prototype works. Now what?
The path from a working prototype to a certified, production-ready product is a project in itself, with its own risks.
Not approvable
The product fails certification: CE, FCC, or industry-specific standards are not met.
Costs explode
Production costs blow up the business plan because processes are used that don't scale for series production.
Time-to-market missed
Investors lose patience. The transition to series production takes longer than planned because the complexity was underestimated.
Development through production: everything from a single source
The complete product lifecycle
Regulatory compliance & production handover
We ensure regulatory compliance and guide the transition to series production. So you have production costs under control and can stick to your business plan.
- Circuit design, PCB layout, and firmware, optimized for series production from the start
- Design for Manufacturing (DFM), so your product can be produced efficiently
- Certification (CE, FCC, RoHS): we manage the entire process
- Series production: setup and supervision of the manufacturing line
- Cost-down phase: ongoing optimization of unit costs after series launch through component selection, supplier changes, and process improvements
Regulatory know-how from life sciences
Our regulatory know-how from the life sciences sector safeguards your certification. We know how certified systems work because we regularly implement them for regulated industries.
What we manage
We guide you through the entire approval process. From the first risk assessment to CE marking, REACH documentation, and industry-specific standards.
EU Product Approval
- Approval Management
Planning and coordination of all approval activities
- CE Marking
Declaration of conformity and technical documentation
- LVD (2014/35/EU)
Low Voltage Directive, electrical safety
- EMC (EN 301 489 / CISPR 32)
Electromagnetic compatibility testing
Radio & Wireless
- RED (2014/53/EU)
Radio Equipment Directive, approval for radio devices
- Bluetooth SIG Registration
Listing as a Bluetooth product
- SAR / EN 62479
Assessment of RF exposure
Materials & Environment
- RoHS
Restriction of hazardous substances, documentation
- REACH
Chemical registration, SVHC documentation
- WEEE / ERA
WEEE registration with the Austrian coordination office
Safety & Risk
- Risk Assessment (moderation)
Structured product risk analysis per ISO 12100
- IEC 14971
Risk management for medical devices
- ISO 23659
Safety of inflatable systems in trampoline sports
Medical
- IEC 60601-1
Safety of medical electrical equipment
- IEC 62304
Software lifecycle for medical devices
- IEC 62366
Usability engineering for medical devices
- ISO 10993
Biocompatibility of materials
- IEC 61010
Safety of laboratory and measurement equipment
Industry-specific
- EN 50155 (Railway)
Electronics on railway vehicles
- IEC 62443
Cyber security for industrial automation
- IEC 81001-5-1
Cyber security for medical device software
- EN 303 645
Cyber security for consumer IoT
- Cyber Resilience Act
EU regulation for products with digital elements
Your partner for the transition to series production
Electronics, firmware, PCB design, certification, manufacturing: all from a single source
Directly from Vienna: personal support, no call center communication
You focus on the business. We make the product.