- Clinical Evaluations for Medical Devices acc. to MEDDEV 2.7/1 rev. 4 and Regulation (EU) 2017/745 (MDR) as well as TGA and MHRA regulations- Biological Safety Evaluations acc. to ISO 10993 (FDA guidance), ISO 18562 and ISO 14971- Performance Evaluations acc. to Regulation (EU) 2017/746 (IVDR)- Biostatistics: Sample size estimation and data analysis acc. to ISO 14155 and MDR, PMS trend analysis- objective and replicable literature research (Pubmed, Embase, Cochrane, etc.)

- Clinical Evaluations for Medical Devices acc. to MEDDEV 2.7/1 rev. 4 and Regulation (EU) 2017/745 (MDR) as well as TGA and MHRA regulations- Biological Safety Evaluations acc. to ISO 10993 (FDA guidance), ISO 18562 and ISO 14971- Performance Evaluations acc. to Regulation (EU) 2017/746 (IVDR)- Biostatistics: Sample size estimation and data analysis acc. to ISO 14155 and MDR, PMS trend analysis- objective and replicable literature research (Pubmed, Embase, Cochrane, etc.)

- Review und preparation of clinical study documentation, e.g. investigator's brochure, study protocol, CRFs, AE-forms, informed consent forms, CTDs- Review and preparation of pre-clinical and clinical study reports.- Pharmacovigilance: review and preparation of PSMF acc. to GVP Module II; ICSRs acc. to E2B(R3); handling of pharmacovigilance database;

Neuropharmacology, neurophysiology and neurodegenerative diseases, elektrophysiology.

Consultancy in handling of research animals for basic research in neurophysiology, monitoring of the animals state and wellbeing, deal with and act acc. to the German Animal Welfare Law, advice in the process of application and execution of experimental studies using animals for research. Support in preparation of the documentation for application.

Theoretical and practical training of students of all ages as well as their teachers in various fields of Neuroscience.