Expertise

Expertise to support you
You will find our team of 44 personnel to be a valuable resource to your R&D. Our expertise and facilities can provide you with what you need to realize your goals.

We make it our business to understand your business, your customer and the people who use your product.

By engaging our support, your development needs can be met and delivered. The cross-functional approach we take to product development is designed to save you time.

Mechanical Engineering
		The mechanical engineers work collaboratively on construction, complex design development, verification and validation. • Mechanical engineering/product construction 3D/CAD • Analysis (strength/fatigue, flow etc.) • Material knowledge –titanium, aluminum, polymers etc. • Design for manufacturing and assembly • Prototyping

Hardware & Software Engineering
	The hardware and software engineers offer extensive experience in analog and digital hardware design, verification and validation. • System design • Integrated electronics • Signal processing • Real-time systems • Wireless communication

Design – Product and Interaction design
	From the start the designers absorb insights, transferring them into physical and commercial benefits. • User insights • Brainstorming & visualization • Ergonomics • Concepts/detail design

Project Management
	Our project managers combine their strong interpersonal skills with their professional approach to planning and management. We make it easy for you to monitor your project’s progress, price performance and results.

Regulatory Affairs and Quality Assurance

We manage projects and product development in all classes (MDD class I-III) for regulatory compliance EU, FDA. Our Regulatory Affairs consultants/partners are qualified to consult on quality systems for medical device products (ISO 13485, QSR, 510K) and regulatory compliance such as CE marking and FDA registrations. We support clients with the compliance and certification of medical devices for; EU, USA, (Japan, Australia, Canada).

 

DEVELOPMENT

Innovation Room
The purpose built Innovation Room is used to facilitate innovation workshops for our clients and project teams.

Workshops
We offer in-house facilities such as a mechanical workshop, an electronics workshop and a medical laboratory from which we can supply: 

•	Quality models
•	Prototypes
•	0-series
•	Lab testing
•	Material for pre-clinical trials

Security
The facilities we provide are secure and audited by the authorities.