Andreas Seidl
Interim Head for Risk Management and Usability
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
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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)
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