Our services for you
Whether you are new to medical technology, want to expand your portfolio or analyze competitors – senetics consulting supports you holistically. Our comprehensive network and many years of industry experience ensure sustainable success of our consulting for your company.
Medical Device Regulation (MDR)
The new Medical Device Regulation (MDR) has been in its final version since 2017. It is correspondingly necessary to implement the current version of DIN EN ISO 13485: 2016. You should already be dealing with the most important implications for your own products and upcoming projects.
In-vitro Diagnostic Regulation (IVDR)
The equally new published In-vitro Diagnostic Regulation (IVDR) – in which there are comprehensive reclassifications of products – will lead to a significantly higher number of manufacturers that have to go through an audit by a notified body, you should prepare for it!
DIN EN ISO 13485:2016 and DIN EN ISO 9001:2015
The changes of the revised quality management standards DIN EN ISO 13485 and DIN EN ISO 9001 must be included in the QM systems. Due to the newly introduced high-level structure of 9001: 2015, especially companies that use an integrated QM system from both standards are faced with the question of whether and how this can be efficiently continued.
Holistic consulting of senetics:
Save yourself and your team time and nerves by eliminating ambiguities with us at an early stage. We are happy to support you with:
- Consultation and support in implementing a gap analysis according to DIN EN ISO 13485: 2016
- Consultation and support in the implementation of a gap analysis according to DIN EN ISO 9001: 2015
- Consultation on the new introduction of a QM system for medical devices compliant with DIN EN ISO 13485: 2016
- Support in the implementation of an integrated QM system of DIN EN ISO 13485 and DIN EN ISO 9001
- Training on the new MDR, its changes, transitional periods and their effects
- Training on IVDR and the increased requirements for manufacturers of in vitro diagnostic medical devices
- Consultation and support for the MDR and standards-compliant approval of your medical device
Of course, we will create an individual offer tailored to your needs.