Clinical Quality Assurance
The harmonized standards for the quality management DIN EN ISO 9001 and DIN EN ISO 13485 are relevant for you as manufacturer of medical devices. They give clear instructions in this regard. For the conduct of clinical studies ISO 14155 is a further relevant harmonized standard.
Besides monitoring as a tool of quality control, audit and inspections are further measures in terms of quality assurance. An essential tool in this context is the existence of a quality management system, which is applied in practice.
We support you during the adaptation of your quality management to fulfill the requirements.
The following services are available:
- Preparation of SOPs in the field of clinical research
- Specific adaptation of SOPs in accordance with your requirements
- Update of SOPs after revised regulatory requirements
- Conduct of audits (system audits, supplier audits, study site audits, sponsor audits)
- Support prior to inspections