Changes in regulatory requirements are part of everyday life in the development and manufacture of medical devices. For seleon’s consultants, quickly grasping the consequences and working through them in a way that is comprehensible and results-oriented for the customer is a daily challenge.
We implement new processes or optimize existing ones for you:
- Preparation of a delta analysis of the existing processes to new/changed regulatory requirements.
- Design and implementation of the necessary new or modified processes or process elements
- Adaptation of the associated process- and QM-relevant documentation
- Provision of traceability analyses for the process-related requirements from the applicable standards
- Training of the new or modified processes
- Coaching during external audits
- Support in the implementation of improvement potentials
Process recording/structuring and modeling
Our experienced consultants draw on the company’s own knowledge of the other two core areas of development and production of sophisticated medical technology. We support you with:
- Recording and analysis of your existing processes (consistency and logic, amount of roles involved, interfaces, media breaks, etc.)
- Development of a new and efficient process model that takes into account all involved areas, disciplines, roles as well as project types and processes
- Presentation of the new processes with modern visualization tools. We rise to the challenge:
- Despite lean processes, all regulatory requirements (CE, FDA, etc.) should be met automatically.
- The required documentation must contain the regulatory minimum as well as secure the existing know-how in a person-neutral way.
Efficiency increase and cycle time reduction
Our in-depth expertise is based on the realization of numerous international development and manufacturing projects in medical technology. With our consulting services, we map the entire product lifecycle (PLM) process. We support you with the:
- Determining the efficiency potential of your PLM processes through structured interviews of your key players
- Analysis and evaluation of process and interface complexity and efficiency
- Introduction, evaluation and optimization of key performance indicators in the entire PLM area
- Analysis, evaluation and optimization of cost structures
- Targeted implementation of measures to reduce rework
- Optimization of your product portfolio through platform concepts, variant optimization and complexity reduction
- Consulting and project support for the selection, configuration, introduction and optimization of software tools to support your PLM processes (ALM tools, such as POLARION, JIRA etc., PDM tools)
Holistic process approach for hardware/software development, risk management, usability and associated documentation
Due to the increasing complexity of medical devices, the need for consistent and methodically prepared documentation (design control) is also growing. In particular the FDA, but also increasingly the notified bodies in Europe show a growing tendency to reject incomplete or non-transparent regulatory documents. Our approach is to create a closer fusion of device architecture and lifecycle activities with the documents accompanying the development. We realize this through a consistent layered model that takes advantage of the logical layers of the V-model, and combine this with a modularization concept that provides a consistent set of documents for each subsystem of the medical device. The documents belonging to a subsystem are clearly presented in a design control chart, which makes it much easier for you to conduct a successful audit.
Complex risk management and sophisticated safety concepts
Our experienced consultants ensure the sustainable safety of your products:
- Carrying out a hazard analysis based on the functional analysis
- Assignment of medical risks with clinical data
- Carrying out risk analyses for assemblies, products and systems
- Definition of essential performance characteristics
- Conception of safety concepts and specifications (safety cases)
- Creation of a safety-related architecture for PEMS and PESS