Analysis
of your company / organization with respect to the maturity of applied processes and cross organizational collaboration.
Re-focusing of the business processes to better achieve targeted goals. Benchmarking of your company / organization against relevant reference standards, like ISO 9001, ISO 13485, SPICE (ISO 15504), CMMI Appraisals, ITIL, among others.
Elaboration
Establishment of a process improvement initiative to achieve agreed goals. Support of teams, processes and tools. Continuous improvement in a learning organization.
Institutionalization
Managing change successfully by enabling employees and managers to professionalize their capabilities for their assigned roles. Our means are role specific training and coaching as well as certification and assessment of adherent behavior.
Success and continuous improvement
Sustainable success of a company can only be achieved by repeated impulses and management of teams by agreed objectives. Processes require ongoing management attention and commitment. Involving affected people from the very beginning will result in better acceptance and sustainable change.
We support you in applying global and country specific regulatory requirements in your medical device development.
You will profit from our profound experience in design quality support and audit preparation for medical devices for the European market (EN ISO 13485, 14971, 62304, 62366, etc.) and for the US American market (FDA Quality System Regulation 21CFR820, 21CFR11, etc.)
Have you lost trust in your software projects? Or shall your team be empowered to apply professional methods in software engineering?
Red-Expel consultants create a competitive advantage for your team by introducing modern methods in software and systems engineering.
Teams and project leaders receive training’s and coaching on the job to various topics: Project and Quality Management, Requirements Engineering, Architecture and Design, System Integration and Test Automation, Configurations and Release Management, Geographically Distributed Development.
