Medical devices are subject to strict quality assurance requirements. This applies both to certification and approval procedures and to quality management of production and processes. In principle, medical devices must meet specific performance and safety requirements throughout Germany and Europe. This is determined in the course of a conformity assessment procedure. A quality management system monitors the entire production cycle – starting with the supply of materials through to product delivery. Central to this is that the product should meet customer requirements, production targets and regulatory and normative requirements. The tasks dovetail closely with regulatory, manufacturing and R&D activities. Medical device manufacturers who demonstrate a quality management system in accordance with DIN EN ISO 13485 can thus prove that their medical product meets the basic requirements in terms of quality assurance or quality. Quality assurance of measurement technology, quality assurance of tools and quality assurance of manufacturing also fall into this category, as do quality assurance in incoming goods (incoming goods inspection) and quality assurance in outgoing goods. New technology methods are currently subject to the development of extended quality standards. These standards are currently being developed and thus also underpin the importance of a mature QM model in the future. Technology is becoming more complex – as are the manufacturing and production processes. The normative framework will evolve along with it. The same must apply to the respective company.
The refinement of quality management – and the focus on new topics and innovations is typically a process in which expertise is brought in from outside. With our resource solutions we help to solve project bottlenecks to the point. With flexible temporary experts – or selected permanent employees who become part of the customer’s team structure. In this way, the company acquires important know-how from outside and can adapt to future changes at an early stage.
Our service areas for fixed and flexible resource solutions:
- Planning, implementation, maintenance and further development of the quality management system according to EN ISO 13485, IVDD/ IVDR, ISO 13485 according to MDSAP
- Execution and implementation of the CAPA process (Corrective and Preventive Action) along the standards ISO 13485, 21 CFR 820
- Collaboration in product development projects, especially in the preparation of the risk management file and the technical documentation
- Support of the approval projects according to the regulatory requirements
- Identification and implementation of improvements and changes to the QM management system incl. root cause analysis and definition and implementation of measures in case of internal malfunctions
- Supervision of conformity assessment procedures and approval procedures in European countries
- Creation, maintenance, management and updating of Q documents (VAs, AAs, technical documentation)
- Implementation of internal quality audits / support of supplier audits
- Complaint management
- Preparation of reports and test plans