Regulatory Affairs
Benefit from the extensive and long-standing experience of our experts: We accompany the entire process, from consulting to approval requirements, standard-compliant development and production through to the certification of medical devices.
JÜKE Systemtechnik GmbH
Altenberge,
Germany
-
Regulatory Affairs: standard-compliant through approval -
-
Quality management in accordance with current norms and standards
Benefit from the extensive and long-standing experience of our experts:
- Consulting, concept development and implementation support
- Quality and risk management
- CE and FDA-compliant documentation
- CE conformity assessment
- Support for CB type testing
- Regulatory support in accordance with MDR and CFR820
- Standard-compliant design transfer and product launch
Get more information about Regulatory Affairs here.
Our brochure is available for download.
