From idea to CE marking
We can offer expertise and a complete structure, facilities and tools in a proven development model that reduces both costs and expensive iterations during the production process.
Due to our ISO 13485 certified quality management system (QMS), Technolution can handle the entire process from idea to finished product and CE marking.
Regulatory requirements and standards impose stricter requirements for the development and approval of Medical Devices. At Technolution, we are ahead of the unique demands for the development of Medical Devices and continuously build “best practices” for processes, activities and documentation, and implement them in our own quality management system.
Our quality management system ensures high quality and efficiency in our services, whether projects and activities are taking place on the clients’ premises or Technolution’s premises.
- Human factor engineering
- Requirements Specification
- Design Control
- Process Validation
- Usability engineering (IEC 62366)
- Mechanical Engineering
- Injection Molding
- Design for Compliance to regulatory requirements and standards
- Product Design Verification
- Product Design Validation
- Risk Management (ISO 14971)
- Pilot preparation and run-in