Dr. Gerd Juhl

Education

1967-1973: Study of electrical engineering at the Technical University of Munich, Germany; University degree of electrical engineering (Diploma), Institute of High Frequency Engineering
1973-1979: Study of human medicine at the University of Munich, State-Examination, Approbation
1978-1979: Resident at the Town Hospital in Landshut, department of internal medicine; Resident at the Town Hospital Muenchen Schwabing, Neurosurgical Department. Resident at the Eye clinic of the University Munich and the Herzog Carl Theodor Eyeclinic in Munich
1980: Promotion to Doctor of Medical Science (Dr.med.), University of Munich
1989: Acknowledgement as specialist in anaesthesiology and intensive care medicine

Work Experience

1980-1982: Resident at the Town Hospital (Poliklinik) of the University of Munich, Department of Anaesthesiology (anaesthesia, intensive care medicine)
1982-1984: Ward physician at the Town hospital Hamburg-Wandsbek, Department of internal medicine (general medicine, pulmonology, cardiology, gastroenterology, diabetology, emergency care).
1984-1989: Institute for Anaesthesiology of the University of Munich, and Department of Experimental Anaesthesia, (anaesthesia, emergency care, clinical research). Preparation and conduct of clinical drug and device investigations. Scientific management of diploma and doctoreal theses
1985-1988: Yearly substitution as a General Practitioner. Holding courses in emergency medicine for medical students and the municipal firebrigade of Munich
1989-1998: Employment at Test house and Notified Body TÜV Product Service GmbH, Munich
1991-1995: Responsibility for functional safety and the assessment of computer hard- and software of medical devices
1992-1995: Head of the Department of Extracorporeal Circulation
1995-1998: Member of the certification body (ZAS). Deputy to the ZAS department head
1996-1998: Head of the Department of Clinical Affairs, responsible for clinical evaluation (MDD, AIMD), responsible for the consultation procedure with European drug authorities.
1998-2012: Principal consultant at Quintiles Consulting
since 2012: Clinical Consultant at MTC GmbH

Regulatory expertise

CE-marking of active and non active medical devices, active implantable medical devices, risk management, preparation of regulatory dossiers, management of drug device combinations, preparation of consultation files

Technical expertise

Device testing, computer control systems, functional safety, software

Clinical expertise

Preparation of clinical investigation plans, clinical investigation reports and clinical evaluation reports in the fields of anaesthesiology, intensive care, emergency medicine, surgery, wound care, infusion, transfusion, internal medicine, dialysis, cardiology, pulmology, dermatology, ophthalmology, urology, orthopedia, gynaecology, neurology, general medicine and interventional treatment methods

Publications

Juhl, G., [The Infucommand. A PCA (patient-controlled analgesia) device using pulsoximetric bolus control]. Anaesthesist 1990;39(4):236-239.
Juhl G, Patientenkontrollierte Analgesie (PCA), in: Neue Technologien in Infusionstherapie und Monitoring, K.J. Doenicke A, Editor. 1990, B.Braun Melsungen AG: Melsungen.
Suttmann, H. and Juhl, G., [Computer-controlled infusion]. Anaesthesist 1988;37(8):558-561.
Bley, H., (Editor), Kompendium Medizin + Technik, Forum-Medizin Verlagsgesellschaft, 82166 Gräfelfing, 1994.
Schwarz, J.A.: Leitfaden Klinische Prüfungen von Arzneimitteln und Medizinprodukten, Edition Cantor Verlag 2011.
Mundt, C., Sventitskiy, A., Cehelsky, J. E., Patters, A. B., Tservistas, M., Hahn, M. C., Juhl, G., and Devincenzo, J. P., Assessing Modeled CO(2) Retention and Rebreathing of a Facemask Designed for Efficient Delivery of Aerosols to Infants. ISRN Pediatr 2012;2012:721295.

Presentations

Presentations and training courses at the Ludwig Maximilian University of Munich. Conferences and seminars organised by Forum Institute, Medinform, MDT. Lector at University Augsburg Faculty of Law on annual Medical Device Legislation Training Courses.

Client activities

Offering strategic consulting services in particular in European regulatory affairs (CE-marking)
Offering consulting services in the field of clinical evaluation and investigation planning
Preparation of clinical trial files for submission to ethics committees and competent authorities
Representing manufacturers with ethics committee and competent authorities
Preparation of final reports of clinical investigations
Preparation of clinical evaluation reports based on literature according to MDD, Meddev 2.7.1 and Meddev 2.12-2
Preparation of design dossiers for Notified Bodies including performing and/or organizing technical tests
Writing risk management reports according to EN ISO 14971
Writing reports on drug device demarcation issues
Working with manufacturers and competent drug authorities on drug device combinations; preparation of consultation dossiers
Writing scientific reports for submission to notified bodies and authorities
Conduct of clinical study audits

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