Medical devices investigator training
Schlagwörter
Skills
Working in clinical research since more than 10 years with main focus on medical devices (clinical studies, clinical evaluations, project management, medical writing, publications, EC/ CA submission,...)
Projekthistorie
06/2020
-
03/2021
10/2019
-
03/2021
Regulatory Affairs
Forum
the market in accordance with the MDR
03/2019
-
03/2021
Regulatory Affairs
Annual Meeting GQMA/DGPharMed
challenges to solutions"
10/2018
-
03/2021
Regulatory Affairs
Oct 2018 TÜV medical device forum autumn update regarding the MDR
06/2018
-
03/2021
Regulatory Affairs
Euronet CTTF
03/2018
-
03/2021
Regulatory Affairs
DGPharMed annual congress 2018
05/2017
-
03/2021
Regulatory Affairs
May 2017 Clinical evaluations - new requirements with regard to the MDR
12/2016
-
03/2021
MDR update
12/2016
-
03/2021
Regulatory Affairs
B. Braun Stiftung
and benefits
11/2016
-
03/2021
Regulatory Affairs
BVMA
07/2016
-
03/2021
Regulatory Affairs
B. Braun Stiftung
reimbursement and utilization
Jun 2016 Meddev 2.7/1. Rev. 4 revised guideline for clinical evaluations
Jun 2016 Meddev 2.7/1. Rev. 4 revised guideline for clinical evaluations
06/2016
-
03/2021
Regulatory Affairs
Jun 2016 Legal and regulatory aspects of Non-Interventional Studies (NIS)
04/2016
-
03/2021
Regulatory Affairs
B. Braun Stiftung
medical devices for benefit evaluation
01/2016
-
03/2021
Regulatory Affairs
University Duisburg
Dr. med. Markus Hahn, MSc. Friedrich-Ebert-Str. 25 34117 Kassel/Germany
operation as new approaches for future drug development
operation as new approaches for future drug development
12/2015
-
03/2021
Regulatory Affairs
B. Braun Stiftung
devices
11/2015
-
03/2021
Regulatory Affairs
BVMA symposium 2015
09/2015
-
03/2021
Regulatory Affairs
DGPharMed Medizinprodukte
03/2015
-
03/2021
Regulatory Affairs
TÜV Süd Medical device forum 2015
12/2014
-
03/2021
Regulatory Affairs
Forum: Ihr Vortrag als lebendiger Dialog" Forum
11/2014
-
03/2021
Regulatory Affairs
BVMA symposium 2014
11/2014
-
03/2021
Regulatory Affairs
TÜV Süd Sicherheitsbeauftragter Medizintechnik
11/2014
-
03/2021
Regulatory Affairs
Nov 2014 DGPharMed: Risk-based monitoring", Trend, Hype oder wahre Innovation?
07/2014
-
03/2021
Regulatory Affairs
MedTech Pharma Congress
11/2013
-
03/2021
Regulatory Affairs
BVMA symposium
10/2013
-
03/2021
Medical device update
09/2013
-
03/2021
Regulatory Affairs
Lübeck Summer Academy Medical Devices
04/2012
-
03/2021
Train the trainer" Workshop TÜV Rheinland
01/2009
-
03/2021
MP/II
Russia, Italy
01/2006
-
03/2021
Rheumatoid
arthritis
01/2000
-
12/2020
Regulatory Affairs
Hyperlipidemia
* Consulting for preclinical/clinical trial program for an implantable sensor
* Consulting for a 510(k)-approval project for a medical device
* Conduct of several submissions (EC/CA) for medical device studies
* MDR requirements check for clinical evaluations, clinical studies, PMCF/PMS activities
Medical Writing
* Compilation of publications in different indications (neurosurgery, diabetics, orthopedics)
* Preparation of study protocols for medical devices and medicinal products in various
phases and indications
* Preparation of clinical trial reports
* Preparation of investigator brochures for medical devices
* Writing of expert reports for reimbursement issues of medical devices
* Writing of expert opinions about medical devices and demarcation to drugs
Quality Management
* Audits of SOPs for Clinical Affairs for ISO 14155 compliance
* Preparation of SOPs for Clinical Affairs issues for medical devices
* Preparation of a set of SOPs for clinical studies with pharmaceuticals in accordance with
relevant standards (ICH-GCP, AMG)
* Audits of CROs for vendor qualification regarding a medical device study
* External safety officer in accordance with §30 German Medical Device Act
Clinical Evaluations
* Writing of various clinical evaluations for medical devices in accordance with MedDev
2.7.1 (Rev. 2, Rev. 3, Rev. 4) and MDR for diagnostic devices, implants, devices for
surgery, nephrology, urology, oncology, orthopedics, cardiology, combination products
* Continuous support of a medical device manufacturer to structure and adapt the QM
system regarding MedDev 2.7/1 rev. 4 and MDR requirements
* External project manager for clinical evaluations for a large medical device manufacturer
Project Management
* Support of a medical device manufacturer (class IIb, III) regarding update of the technical
documentation from MDD to MDR with focus on clinical evaluations, IfU, project duration:
6 months (2020-2021)
* Interim project manager in the field of interventional cardiology for a medical device
manufacturer regarding support for medical evaluations, project duration: 5 months
(2019-2020)
* Support of a large medical device manufacturer with a huge product portfolio regarding
update of the technical documentation from MDD to MDR (clinical evaluations, IfU),
project duration: 11 months (2017-2018)
* Project management for a clinical study with a medical device in oncology (pre-market),
project duration: 18 months (2012-2013)
* Interim project management for a multinational clinical study with a drug in ophthalmology
in phase III, project duration: 12 months (2011)
* Interim project management for a multinational clinical study with a drug in oncology in
phase II regarding a CRO transition, project duration: 4 months
Dr. med. Markus Hahn, MSc. Friedrich-Ebert-Str. 25 34117 Kassel/Germany
Experiences in different indications:
* Nephrology
* Rheumatology
* Neurology
* Cardiology
* Orthopedics
* Oncology
* Diabetology
* Endocrinology/Fat metabolism
* Surgery
* Plastic surgery
* Intensive medicine
* Psychiatry
* Urology
* Ophthalmology
* Dermatology
* Gynecology
* Nutrition
* Pulmonology
Trainings received:
* Consulting for a 510(k)-approval project for a medical device
* Conduct of several submissions (EC/CA) for medical device studies
* MDR requirements check for clinical evaluations, clinical studies, PMCF/PMS activities
Medical Writing
* Compilation of publications in different indications (neurosurgery, diabetics, orthopedics)
* Preparation of study protocols for medical devices and medicinal products in various
phases and indications
* Preparation of clinical trial reports
* Preparation of investigator brochures for medical devices
* Writing of expert reports for reimbursement issues of medical devices
* Writing of expert opinions about medical devices and demarcation to drugs
Quality Management
* Audits of SOPs for Clinical Affairs for ISO 14155 compliance
* Preparation of SOPs for Clinical Affairs issues for medical devices
* Preparation of a set of SOPs for clinical studies with pharmaceuticals in accordance with
relevant standards (ICH-GCP, AMG)
* Audits of CROs for vendor qualification regarding a medical device study
* External safety officer in accordance with §30 German Medical Device Act
Clinical Evaluations
* Writing of various clinical evaluations for medical devices in accordance with MedDev
2.7.1 (Rev. 2, Rev. 3, Rev. 4) and MDR for diagnostic devices, implants, devices for
surgery, nephrology, urology, oncology, orthopedics, cardiology, combination products
* Continuous support of a medical device manufacturer to structure and adapt the QM
system regarding MedDev 2.7/1 rev. 4 and MDR requirements
* External project manager for clinical evaluations for a large medical device manufacturer
Project Management
* Support of a medical device manufacturer (class IIb, III) regarding update of the technical
documentation from MDD to MDR with focus on clinical evaluations, IfU, project duration:
6 months (2020-2021)
* Interim project manager in the field of interventional cardiology for a medical device
manufacturer regarding support for medical evaluations, project duration: 5 months
(2019-2020)
* Support of a large medical device manufacturer with a huge product portfolio regarding
update of the technical documentation from MDD to MDR (clinical evaluations, IfU),
project duration: 11 months (2017-2018)
* Project management for a clinical study with a medical device in oncology (pre-market),
project duration: 18 months (2012-2013)
* Interim project management for a multinational clinical study with a drug in ophthalmology
in phase III, project duration: 12 months (2011)
* Interim project management for a multinational clinical study with a drug in oncology in
phase II regarding a CRO transition, project duration: 4 months
Dr. med. Markus Hahn, MSc. Friedrich-Ebert-Str. 25 34117 Kassel/Germany
Experiences in different indications:
* Nephrology
* Rheumatology
* Neurology
* Cardiology
* Orthopedics
* Oncology
* Diabetology
* Endocrinology/Fat metabolism
* Surgery
* Plastic surgery
* Intensive medicine
* Psychiatry
* Urology
* Ophthalmology
* Dermatology
* Gynecology
* Nutrition
* Pulmonology
Trainings received:
07/2020
-
10/2020
Regulatory Affairs
AMG/ICH
Jul 2020 Internal training MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for
manufacturers and notified bodies, MDCG 2020-6 Regulation (EU) 2017/745:
Clinical evidence needed for medical devices previously CE marked under
Directives 93/42/EEC or 90/385/EEC
manufacturers and notified bodies, MDCG 2020-6 Regulation (EU) 2017/745:
Clinical evidence needed for medical devices previously CE marked under
Directives 93/42/EEC or 90/385/EEC
04/2019
-
05/2019
Regulatory Affairs
AMG/GCP Advanced training
12/2018
-
02/2019
Regulatory Affairs
MDR
03/2015
-
07/2015
Regulatory Affairs
B.Braun Stiftung
09/2000
-
10/2000
Module about medical device operator legislation
Sep 2000 Basic module of pharmaceutical legislation under consideration of the 10th
amendment of the German Drug Law
Sep 2000 Outsourcing
amendment of the German Drug Law
Sep 2000 Outsourcing
01/1997
-
01/1998
Product Manager
Fresenius HemoCare
Adsorbertechnology in St. Wendel/Germany,
Main topic: Strategic development/Clinical research for DALI LDL
apheresis system
Main topic: Strategic development/Clinical research for DALI LDL
apheresis system
Reisebereitschaft
Verfügbar in den Ländern
Deutschland
