Go to website
Request project
Andreas Seidl
Interim Head for Risk Management and Usability
Grafing bei München, Germany
Experience
Mar 2023 -
Oct 2024
1 year 8 months
Munich, Germany
Interim Head for Risk Management and Usability
Technolas Perfect Vision GmbH
Creation and maintenance of risk management files
Conducting usability studies
Process validation
Support of quality management, among others in maintaining processes for risk management, usability, design control, and CAPA management
May 2022 -
Oct 2022
6 months
Garching, Germany
Project Management for Process Validation
ITM Medical Isotopes GmbH
Coordination of process validation for a new manufacturing of radioactive drugs
Preparation of approval-relevant validation documentation
Jun 2021 -
Apr 2022
11 months
Tuttlingen, Germany
Moderator for Risk Management according to ISO 14971:2019
Karl Storz SE & Co. KG
Risk management for Class III medical devices
Moderation of risk analyses
Revision of risk management processes according to ISO 14971:2019
General support in risk management
Sep 2020 -
Feb 2021
6 months
Mannheim, Germany
Support for the Creation and Implementation of Technical Documentation as well as the Establishment of Production
Vibrosonic GmbH, Mannheim
Product approval for clinical trials
Creation of a DHF
Risk management in coordination with QM, RA, CA, Labeling, R&D, RM, Purchasing
Preparation of technical documentation for national and international approvals
Formative and summative usability evaluation
Validation of manufacturing processes
Jun 2019 -
Apr 2020
11 months
Maisach, Germany
Support for Medical Device Approval
HMT Medizintechnik
Regulatory Affairs Manager
Improvement of the current quality management
Gap analysis of the QM manual
Gap analysis for product and process validations
Establishment of a risk management system according to ISO 14971
Technical documentation according to Annex II of the MDR
Support and coordination for the switch of the Notified Body
Establishment of supplier management according to MDR
Preparation of usability files according to IEC 62366
Feb 2019 -
May 2019
4 months
Berlin, Germany
Support for Medical Device Approval / Head of Technical Documentation
aap Implantate
Creation of a risk management file
Technical documentation for osteosynthesis instruments
Maintenance of open CAPA projects
Apr 2017 -
Dec 2019
1 year 9 months
Munich, Germany
Project Management for the Creation of Technical Documentation
Baxter Europe
Restructuring of design control
Project management for the creation of technical documentation
Preparation of clinical evaluations according to MEDDEV 2.7.1 Rev. 4
Training of external staff
Development of a strategy for the transfer from MDD to MDR
Jun 2016 -
Jan 2017
8 months
Weßling, Germany
Development Project Manager
Dornier MedTec
Management of a development project
Organization of product approval
Preparation of technical documentation for international approvals (MDR, 510(k), etc.)
GAP analysis and improvement/streamlining of existing processes (design control, risk management, post-market surveillance, technical documentation)
GAP analysis and correction of technical documentation
Apr 2016 -
Mar 2017
1 year
Munich, Germany
Risk Manager
PARI Pharma GmbH
Gap analysis of technical documentation for conformity assessment
Risk management review
May 2015 -
Dec 2015
8 months
Munich, Germany
Regulatory Affairs Specialist
Baxter Europe, München
Project management for the merger of the quality management of two companies
Process mapping for design control, risk management and CE approval
Process alignment between quality management systems of different organizations/manufacturers
Introduction of a life-cycle management for conformity assessment to the MDD
Introduction of technical documentation for international approval under the MDR (= 2017/745) of the EU and 510(k) for the USA (= 21 CFR 820)
Staff training
Preparation of so-called STEDs according to GHTF guidelines
Jan 2015 -
May 2015
5 months
Tuttlingen, Germany
CAPA Specialist
Stryker Berchtold
Review and moderation of CAPA projects
Equipment qualification
Process validation (IQ/OQ/PQ)
Apr 2014 -
Oct 2014
7 months
Tuttlingen, Germany
Interim Quality Manager
REDA Instrumente
Support during the re-certification audit
Review of the complete quality management system
Preparation of technical documentation
Introduction of post-market surveillance for PLM without involvement of the OEM
International registration (USA, Canada, Brazil, Colombia, Peru, China)
Nov 2013 -
Mar 2014
5 months
Rastatt, Germany
Interim Quality Management Representative
Maquet Cardiopulmonary
Support in the area of quality management
Review of the QM system for FDA compliance and DIN EN ISO 13485
Management and moderation of CAPA projects
Conducting internal audits
Training in quality management
Supervision of process validations
Aug 2013 -
Nov 2013
4 months
Tuttlingen, Germany
CAPA Management Expert
Johnson und Johnson / Synthes
Review of existing CAPA projects according to FDA 21 CFR 820.100
Preparation of reports for review for FDA inspections
Support for ongoing CAPA projects at branch sites
May 2013 -
Aug 2013
4 months
Aarau, Switzerland
Post Market Surveillance Specialist
Smith & Nephew Orthopaedics AG
Introduction of the post-market surveillance process (PMS)
Definition and preparation of reports within PMS
Preparation of IQ/OQ/PQ plans in the course of relocation of the production facility
Sep 2012 -
Apr 2013
8 months
Tuttlingen, Germany
Quality Manager and Regulatory Affairs
Sopro-Comeg GmbH
Implementation, execution and maintenance of a QM system according to the requirements of the MDD, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordination and execution of actions in the CAPA process
Establishment and moderation of a risk management system according to ISO 14971
Product approval according to legal and normative requirements
Support of development projects in documentation issues according to legal and normative requirements
Jan 2009 -
Aug 2012
2 years 8 months
Tuttlingen, Germany
Regulatory Affairs Manager
KLS Martin Group
Creation and updates of Design History Files according to legal and regulatory requirements
Implementation of legal and normative requirements over the life cycle of a product
Support in coordination and planning of the regulatory part of clinical evaluations, PMCF, and studies
Preparation of dossiers for FDA 510(k) clearances
Establishment of a risk management system according to ISO 14971
Improvement of requirements in existing processes
Establishment of a regulatory affairs management for the entire KLS Martin Group
Jan 2009 -
Jun 2009
6 months
Starnberg, Germany
Quality Manager
StarMedTec GmbH
Coordination of product approvals for the EU, USA and Asia
Implementation, execution and maintenance of a QM system according to the requirements of the MDD, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordination and execution of actions in the CAPA process
Moderation of cross-departmental quality relevant processes
Product approval according to legal and normative requirements
Support of development projects
Apr 2008 -
Dec 2009
9 months
Munich, Germany
Quality Manager
Pulsion Medical Systems AG, München
Implementation, execution and maintenance of a QM system according to the requirements of the MDD, FDA GMP, ISO 13485:2003+A1+A2
Monitoring the application of employed quality tools and associated tests
Representation of the company towards customers and authorities
Coordination of complaint management
Coordination and execution of actions in the CAPA process
Leadership and coordination of the quality assurance department
Process validation and qualification for production (IQ/OQ/PQ)
Introduction of new in-process controls in manufacturing
Conducting internal system and external supplier audits
Mar 2001 -
Mar 2008
7 years 1 month
Munich, Germany
Headquarter Complaint Manager
Agfa Gevaert AG
Moderation among internal departments as well as with external interfaces
Introduction of global processes for post-market surveillance (complaints, CAPA etc.)
Development of statistics and trend reports on product quality
Specification and introduction of a complaint database
Monitoring of complaints recorded in the database with reporting to cross-departmental teams and management
Execution of projects to improve product monitoring
Training on the CAPA process and use of the complaint system
Improvement of QM management processes according to Six Sigma
Introduction of computerized software validation (CSV)
Sep 1998 -
Jan 2001
2 years 5 months
Munich, Germany
Product Specialist
Agfa Gevaert AG
2nd line support for Agfa branches, customers and dealers
Field service for installations and service calls at customers or dealers
Conducting system and device courses
Participation in specifications, validation and introduction of new products
Sep 1993 -
Aug 1998
5 years
Munich, Germany
Product Specialist
TÜV Product Service GmbH
Coordinator for FDA 510(k) approvals
Central coordinator for the approval of medical devices in Japan
Auditor and lead auditor for the acceptance of QM systems according to ISO 9000 / EN 46000, MDD and AIMD in Europe, East Asia and the USA
Expert for the regulatory approval of medical devices
Member of the committee for CE certification
Languages
German
Native
English
Advanced
Education
Lorem ipsum dolor sit amet
Diploma · Medical Engineering · Ulm, Germany
Certifications & licenses
Cybersecurity for Medical Devices and IEC 81001-5-1
Artificial Intelligence (AI) in Medical Engineering
Medical Device Forum, focus on Cybersecurity, AI Act, Data Act
Risk Management within the scope of ISO 9001:2015
Advanced Product Quality Planning – APQP
Process Validation in the Field of Medical Devices
Computerized Systems Validation (CSV)
Developing Medical Software in Compliance with Regulations
Medical Device Single Audit Program (MDSAP)
Share profile
Download
Meet Andreas
Similar Freelancers
Discover other experts with similar qualifications and experience
Verified Expert
Dieudonné Mbarga
PRRC, Quality and Regulatory Representative
View Profile
Verified Expert
Hans Spichiger
Medical Device Product Development Consultant
View Profile
Verified Expert
Timur Güvercinci
Senior Quality Project Expert and Consultant in the Pharmaceutical Industry
View Profile
Verified Expert
Norbert Helmke
Interim Project Manager Ramp-Up Pilot Facility
View Profile
Verified Expert
Monika Weber
Quality Specialist
View Profile
Verified Expert
Thomas Freudemann
Operational Excellence Consultant
View Profile
Verified Expert
Friederike Balaz
Information Security Manager
View Profile
Verified Expert
Rüdiger Schüller
Process Optimization
View Profile
Verified Expert
Peter Sperber
Project Manager / Project Manager / Project Manager
View Profile
Verified Expert
Thomas Kupfer
Consultant/Coach ISO/SAE 21434 / UNECE R-155
View Profile
Verified Expert
Thomas Meidinger
External Officer and Consultant for the Integrated Management System
View Profile
Verified Expert
Nils Novak
Project Manager
View Profile
Verified Expert
Sandra Klinkenberg
Webinar - Raising awareness of BLACKOUT prevention and preparation
View Profile
Verified Expert
Thomas Nowak
Medical Technology Quality Advance Planning
View Profile
Verified Expert
Erik Zimmermann
Quality Management Consultant
View Profile