Medical Technology Development

Our strength is the combination of innovative product development and production skills with excellence within the regulatory requirements for getting a medical device to the market.

With deep knowledge and experience from medical device development according to common standards like ISO 14971,  IEC 62366 and ISO 10993. We will carry out the development of your device through initial research, concept generation, planning, design, verification

& validation.

Our design control process is in accordance with EN ISO 13485

Project Management

All our projects are appointed a project manager with deep technical knowledge. The project manager works in close correlation with each customer and the project team. We normally base the project at our office but also offer the possibility for management at customer site.

Time, cost, quality and communication are the keywords during the entire project. The projects are managed within the Extero design control process or according to the customer’s development model.

Project leaders have long experience in many different type of projects which gives good knowledge in estimating the timeplan and budget from the start.

Engineering

Good design is easy to produce, assemble, use and serve. We offer innovative engineering development solutions for many different markets with these words in focus! We can handle small tasks at customer site as well as full development projects from idea to production in our own office.

Thanks to our experience from industrial design and quality assurance we include these aspects in the product from the first sketches.

Our team has experience from all common manufacturing methods and materials working with many different CAD and PDM systems on the market. 

Quality Assurance

Extero AB strive to become our clients’ first choice for medical device development. Our strength is the combination of innovative product development and production skills with excellence within the regulatory requirements for getting a medical device to the market. This means we develop the technical documentation in parallel with the product which ends up with a safe, functional and user-friendly medical device!

Extero can take on full development projects from idea to CE-mark and production set-up, but also support our clients in sub-projects or as temporary resources.

Production

By thinking about production from the start, time and cost are two main factors that can be reduced. We have experience from many different projects, both medical and industrial, with setting up the production and optimizing it to the costumer needs.

Cost reduction and maintaining high quality are always in focus for the Manufacturing industry. We provide innovative solutions for improved productivity, cost reduction and improved customer satisfaction. Our team has extensive experience from providing solutions for production logistics, assembly fixtures, traceability and test rigs in different industries.