Consultant Medical Devices
(Pharma und Medizintechnik, 50-250 Mitarbeiter)
Schlagwörter
Audits
ISO / IEC 27001
Medizinsches Material
Dokumentation der Prozesse
21 Cfr
Auditmanagement
Medizintechnik
Unternehmensberatung
Change Management
Qualitätsaudit
Skills
Regulatory Affairs Medical Devices
Quality Management (ISO 13485, 21 CFR 820)
Design Controls (21.CFR 820.30)
Product Lifecycle
MDR (EU 2017/745)
FDA Mock Audits
FDA Guidances
Trainings (Established trainer for different topics)
Certified Auditor (QMS, Supplier)
Risk Management (ISO 14971)
Software Lifeccle (IEC 62304, IEC 82304-1, IEC 80002-1)
Cybersecurity (IEC 81001-5-1, IEC 81001-5-2, AAMI TIR 57 + SW 96, ISO 27001)
Usability Engineering (IEC 62366-1)
Project Management
Cultural Change Management
Consultancy Medical Devices
Experiences in different company sizes (Start-up to Enterprise)
Experience in Health Care and Health Delivery Organizations
Experience with MDSAP audits
CISO (ISO 27001)
Quality Management Representative
Person Responsible for Regulatory Compliance
Process Validation
Technical Documentation according to MDR Annex II
Project Management
Quality Management (ISO 13485, 21 CFR 820)
Design Controls (21.CFR 820.30)
Product Lifecycle
MDR (EU 2017/745)
FDA Mock Audits
FDA Guidances
Trainings (Established trainer for different topics)
Certified Auditor (QMS, Supplier)
Risk Management (ISO 14971)
Software Lifeccle (IEC 62304, IEC 82304-1, IEC 80002-1)
Cybersecurity (IEC 81001-5-1, IEC 81001-5-2, AAMI TIR 57 + SW 96, ISO 27001)
Usability Engineering (IEC 62366-1)
Project Management
Cultural Change Management
Consultancy Medical Devices
Experiences in different company sizes (Start-up to Enterprise)
Experience in Health Care and Health Delivery Organizations
Experience with MDSAP audits
CISO (ISO 27001)
Quality Management Representative
Person Responsible for Regulatory Compliance
Process Validation
Technical Documentation according to MDR Annex II
Project Management
Projekthistorie
04/2019
-
bis jetzt
03/2017
-
03/2019
Quality Management Representative and Head of Quality Management
B. Braun Avitum
Active Medical Devices
* Member of the Board
* Responsible for implementation, maintenance and improvement of the quality management system
according to MDD 93/42/EWG, MDR 2017/745, 21 CFR and other international regulations
* Responsible for regulatory compliance in development, production and post-production life cycle
of Active Medical Devices for extracorporeal blood treatment and infusion therapy
* Member of the Board
* Responsible for implementation, maintenance and improvement of the quality management system
according to MDD 93/42/EWG, MDR 2017/745, 21 CFR and other international regulations
* Responsible for regulatory compliance in development, production and post-production life cycle
of Active Medical Devices for extracorporeal blood treatment and infusion therapy
03/2014
-
02/2017
Quality Manager
B. Braun Avitum
* Responsible for compliance of development of Active Medical Devices (hemodialysis and Medical
Software) according to ISO 13485, 21 CFR 820, ISO 14971, IEC 62366, IEC 62304, IEC 60601
* Quality Management Auditor (TÜV/SGS)
Software) according to ISO 13485, 21 CFR 820, ISO 14971, IEC 62366, IEC 62304, IEC 60601
* Quality Management Auditor (TÜV/SGS)
07/2001
-
02/2014
Project Engineer
iSYMED GmbH (former MedVision AG)
business, Project Manager Patient Data Management Systems in hemodialysis (Active Medical Device)
* Project Management and Responsibility
* Performing software life cycle process according to IEC 62304 and ISO 14971, programming in C++,
C#, ASP.NET
* Establishing hardware/software interfaces to dialysis machines according to IEC 60601-1, IEC
60601-1-x, IEC 60601-2-16
* Creation of training material for users and technicians, managing and performing international
trainings
* Supporting international product approval processes, e.g. EC conformity assessment, FDA 510(K)
* Project Management and Responsibility
* Performing software life cycle process according to IEC 62304 and ISO 14971, programming in C++,
C#, ASP.NET
* Establishing hardware/software interfaces to dialysis machines according to IEC 60601-1, IEC
60601-1-x, IEC 60601-2-16
* Creation of training material for users and technicians, managing and performing international
trainings
* Supporting international product approval processes, e.g. EC conformity assessment, FDA 510(K)
07/2000
-
06/2001
Development Engineer
Fresenius Medical Care
active medical devices (hemo dialysis and peritoneal dialysis)
* Planning and performing of laboratory experiments
* Requirements engineering for medical software
* Performing risk analysis according to EN 1441
* Development and supervision of a department for final testing
* Planning and performing of laboratory experiments
* Requirements engineering for medical software
* Performing risk analysis according to EN 1441
* Development and supervision of a department for final testing
06/1996
-
07/1996
Male nurse
Emergency Room of Medical Centre
Reisebereitschaft
Weltweit verfügbar
