Due to many years of experience in development and approval of medical devices, as well as the support of reputable companies in international quality assurance projects we are your competent partner.
Quality Assurance
We offer extensive assistance in the field of quality assurance. Whether it is the professional development of a complete quality management system according to your requirements or competent support of international quality assurance projects
We provide individual consulting in the area of quality. Our range extends from ISO 9001 or ISO 13485 via 21CFR820 of FDA, into the region of the device approval / regulatory affairs (CE / MDD, FDA / UL / CSA) . If you need help on specific standards such as IEC 60601-1 series, ISO 14971 , EN12182 or IEC 62304, contact us.
Development
Depending on customers’ need we provide any part of the development process, such as project planning, development of optical systems or laser components, advisory support or expertly prepared feasibility studies.
For various areas we work in collaboration with partners - all experienced specialists in their fields. Ernst Invent has built this network around the theme of development. It therefore allows us to offer you the full range of development services, from feasibility studies to complete development projects in the field of laser systems and medical devices.
You are free to decide with regard to your own resources - which part of the development process, we should take care of on your behave - or whether you are seeking a solution for the entire project from one source.
