Full coverage of device documentation for your regulatory compliance
We develop for our clients complete device files according to
- MDR (2017/745/EU)
- IVDR (2017/746/EU) and
- QSR (21 CFR 820)
Our customized database apps significantly reduce the time that is typically needed to fulfill Annex I and Annex II requirements of the MDR/IVDR.
We collaborate with a network of consultants and partner companies in complex project situations.
With this setting, we are able to provide real turn-key solutions from concept development to serial production.
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
When it comes to quality management systems and document handling with integrated work-flow management, we recommend Stendard Solution, a cloud-based service of Stendard .
Stendard is a Singapore-based regulatory consultancy and technology company that helps businesses to implement international standards, streamline business processes across the organisation, and accelerate global growth
adjutem supports clients to integrate Stendard Solution into their organization.
Jüke Systemtechnik 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.