Product Manager, MP/II, Rheumatoid

Oct 2018 TÜV medical device forum autumn update regarding the MDR

May 2017 Clinical evaluations - new requirements with regard to the MDR

and benefits

reimbursement and utilization
Jun 2016 Meddev 2.7/1. Rev. 4 revised guideline for clinical evaluations

Jun 2016 Legal and regulatory aspects of Non-Interventional Studies (NIS)

medical devices for benefit evaluation

Dr. med. Markus Hahn, MSc. Friedrich-Ebert-Str. 25 34117 Kassel/Germany



operation as new approaches for future drug development

devices

Nov 2014 DGPharMed: Risk-based monitoring", Trend, Hype oder wahre Innovation?

Russia, Italy

arthritis

* 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:

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

Sep 2000 Basic module of pharmaceutical legislation under consideration of the 10th
amendment of the German Drug Law
Sep 2000 Outsourcing

Adsorbertechnology in St. Wendel/Germany,
Main topic: Strategic development/Clinical research for DALI LDL
apheresis system