Technical Files, DHF, DMR, V&V Tools and Compliance Software
We develop for our clients complete device documentation in accordance with
- MDR (2017/745/EU)
- IVDR (2017/746/EU) and
- QSR (21 CFR 820)
Small companies and start-ups often need effective and customized ready-to-use quality management systems with full coverage of ISO 13485 requirements.
This is where we can help with proven QMS structures and processes.
Our customized database app significantly reduce the time that is typically needed to comply with Annex I and Annex II of the MDR/IVDR.
We collaborate with a network of consultants and partner companies in complex project settings:
The MDR COMPETENCE network supports clients by:
- providing guidance to quality and risk related questions
- supporting transition planning (MDD to MDR) -helping with strategy planning and finance consulting
- supporting due diligence activities and M&A activities
- providing guidance to clinical trial planning and clinical evaluation reporting
JÜKE is a system integrator that distinguishes itself through a wide production range from machining to production and assembly to quality control – all from one source.
The know-how comes from a long-standing pool of knowledge in precision mechanics, precision engineering, mechatronics, electronics as well as firmware and software development at the embedded level. In addition, we can contribute profitably our cross-industry experience in medical technology, optical technology and laboratory technology to customer projects.
We collaborate with JÜKE to combine design and production competences with regulatory assistance. By this, we can offer a full design and development service for medical devices and IVD systems including CE certification and serial production.