Our philosophy
We can take your product all the way from idea to approval
- or step in to support specific parts of the journey. From concept and prototyping to regulatory strategy and CE marking, we help you bring safe, effective devices to market.
Concept + Design + MDR Compliance = Market-Ready Device
→ We don’t just advise - we can take your product all the way from idea to approval, or support with specific parts where you need extra expertise.
Hybrid Design supports medtech companies through every stage of the product journey - from early concept and design, through regulatory strategy, quality systems and verification, all the way to CE marking and market launch. Whether you need a complete development partner or assistance with a single step - such as risk management, usability, prototyping or technical documentation - our team integrates seamlessly into your process.
With deep experience in MDR and ISO 13485, we combine technical excellence with a pragmatic approach, ensuring that innovation and compliance evolve hand in hand. The result: safe, effective products ready for the market.
Practical Knowledge
Our approach is rooted in hands-on experience of developing and designing medical devices - from early concepts to functional prototypes and validated products. With strong capabilities in industrial design, engineering and usability, we translate ideas into tangible solutions that meet both user needs and regulatory expectations. By integrating design control early in the process, we ensure efficient iteration, clear documentation and a smooth path to verification.
01. Concept & Industrial Design
02. Mechanical Design & Prototyping
03. Usability Engineering & UX
04. Design Control & Verification Planning
Engineering Design
Medical device development with Hybrid Design is a seamless integration of engineering, regulatory strategy and human-centred design. Inspired by Nordic clarity and precision, we work collaboratively with our clients in an iterative process - guiding each project from concept to compliant, manufacturable product. Our approach combines functional excellence with a clear design identity that supports both usability and market positioning.
01.
02.
03.
04.
05.
06.
07.
08.
Brand-Coherent Product Design
Photo-Realistic Renderings
Marketing & Regulatory Visuals
CMF (Color, Material & Finishes)
Industrial & Product Design
User Interface & Ergonomics
Usability & Human Factors Integration
Concept Development & Prototyping
In-House Regulatory Expertise
Combining advanced design capabilities with deep regulatory knowledge, we integrate MDR and ISO 13485 requirements into every stage of development. Our team works closely with regulatory consultants, notified bodies and testing partners to ensure compliance is built in from the start - not added at the end. From early concept to technical documentation and verification, regulations guide the entire process.
01.
02.
03.
04.
Design & Risk Management
Usability Engineering
Technical Documentation
Prototyping & Verification
05.
06.
07.
08.
GSPR & Regulatory Assessment
Clinical & Performance Planning
Quality System Integration (ISO 13485)
CE Marking Strategy under MDR
