Through strategic quality management, we help you to constantly optimise your product development ... We offer advice!
Our expertise
We have many years of experience in auditing quality management systems according to European and international requirements, as well as in the evaluation of technical documentation.
Above all, our aim is to make a major contribution to making your medical products safer and to sensitise you to align and optimise your processes accordingly.
Appropriate lean management, including the corresponding tools, can also have positive effects on process costs.
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Management Consulting
- Supporting Sections:
- Strategic corporate management and planning
- Strategy development
- Mission statement development
- Corporate optimization and reorganization
- Quality management system according to:
- ISO 9001
- ISO 13485
- ISO 14001 (Environmental Management)
- Medical Device Single Audit Program (MDSAP)
- UKCA - Technical documentation audit according to MDD 93/42/EEC
- Technical documentation audit according to MDR 2017/745
- Communication with certification bodies
- Project management and risk assessment
- Coaching in the development of a quality management system according to ISO 9001, ISO 13485 & MDSAP-Approach
- Coaching and Training of Integrated Management Systems like ISO 14001
. - Coaching in the creation of quality documents (QMH, SOPs, process description, work instructions, etc...)
Interims Management in the areas of:
- Crisis Management:
- Implementation of reorganisations and restructurings
- Implementation of reorganisations and restructurings
- Bridging staff shortages
- Implementation of:
- Strategic corporate management and planning
- Strategy developments
- Mission statement development
- Project management
- Relationship and conflict management
-
Strategic and operational controlling
- Company analysis (weak point analysis)
- Cost optimisation
Do you have any further questions?
We will be happy to answer them!
Use our practical contact form or call us now without obligation at +49 1525 846 12 75. We will also be happy to advise you directly on site.
