Clinical Affairs deals with the issues surrounding the clinical application of a medical device. The aim of the activities is to prove that the medical device actually provides the clinical benefit in practical use. The clinical benefit of the product must be substantiated with data and observed and confirmed throughout the entire product life cycle.
With our resource solutions, we help solve project bottlenecks to the point. With flexible temporary experts – or selected permanent employees who become part of the customer’s team structure.
The MDR tightens the requirements for clinical evaluations. We offer the customer immediate expert support here – also interlinked with the additional areas of risk management, quality management and post-market surveillance (PMS).
Our service areas for fixed and flexible resource solutions:
- Development of a Clinical Strategy Plan (CSP)
- Creation of standard operating procedures (SOP) for uniform project implementation
- Test plan development and statistics planning
- Know-How in all regulatory requirements (ICH-GCP, ISO 14155, MPG, MDR, MDD (93/42/EEC), MEDDEV documents)
- Cost planning and project management
- Study design and recruitment of study participants
- Creation of standard operating procedures (SOP) for uniform project implementation Global study execution and monitoring (documentation, execution, follow-up, local regulation)
- Literature research and market monitoring
- Preparation of study documents (protocol, eCRFs, patient information, investigator folders).
- Market Monitoring and Post-Market Surveillance (PMS)