Andreas Seidl-Consulting for quality management and regulatory affairs in medical technology
Check rate
Experience
Consulting on quality management and regulatory affairs
Curevius GmbH
Manufacturer of medical devices
- Creation and further development of quality management systems according to EN ISO 13485
- Gap analysis of existing quality management systems according to ISO 13485
- Consulting and support in customer projects in the field of quality management and
- Proof of regulatory compliance for medical devices of all risk classes
- Preparation of technical documentation according to MDR
- Gap analysis of the risk management file according to ISO 14971:2019
Interim manager for risk management and usability
Technolas Perfect Vision GmbH
- Creation and maintenance of risk management files for ophthalmology devices
- Creation of a risk analysis for cybersecurity according to MDCG 2019/016, IEC 81001-5-1
- Review of software safety according to IEC 62304
- Conducting usability studies according to IEC 62366
- Process validation (process FMEA, IQ/OQ/PQ)
- Maintenance of SOPs, work instructions, etc. for risk management, usability, design control and CAPA management according to ISO 13485
- Support of FDA approval for Class 3 products according to GMP (21 CFR Part 814)
Project management for process validation
ITM Medical Isotopes GmbH
- Coordination of process validation (URS, pFMEA) for a new manufacturing facility for radiopharmaceuticals
- Preparation of the approval-relevant validation documentation according to the Medicinal Products Regulation (EU) 2021/228
Moderator for risk management according to ISO 14971:2019
Karl Storz SE & Co. KG
- Moderation of risk analyses for Class III medical devices
- Risk management according to ISO 14971:2019
- Revision of the SOP for risk management according to ISO 14971:2019
Technical documentation according to Annex II MDR as well as product establishment
Vibrosonic GmbH
- Creation of a Design History File (DHF)
- Lead of an interdisciplinary team for risk management according to ISO 14971
- Preparation of technical documentation for national and international approval (510k, MDR Annex II, STED)
- Formative and summative usability evaluation according to IEC 62366
- Validation of manufacturing processes (pFMEA, DQ/IQ/OQ/PQ)
Regulatory Affairs Manager
HMT Medizintechnik
- Improvement of the current quality management manual (SOPs, work instructions, etc.)
- Gap analysis of product and process validations (process FMEA, DQ/IQ/OQ/PQ)
- Development of a risk management system according to ISO 14971
- Technical documentation in accordance with Annex II of the MDR (2017/745/EC)
- Support and coordination during the change of notified body for certification according to ISO 13485 and MDR
- Development of a supplier management system
- Creation of usability files according to IEC 62366
Support for the approval of medical devices
aap Implantate
- Creation of a risk management file according to ISO 14971
- Technical documentation for osteosynthesis products according to MDR (2017/745/EC), FDA 510(k), etc.
- Maintenance of open CAPA projects
Project management for the creation of technical documentation
Baxter Europe
- Restructuring of the design control process (SOPs, work instructions)
- Creation of technical documentation (STED according to GHTF/IMDRF)
- Creation of clinical evaluations according to MEDDEV 2.7.1 Rev. 4
- Training of external employees
- Development of a strategy for the transfer from MDD (93/42/EEC) to MDR (2017/745/EC)
Project Manager Development
Dornier MedTec
- Management of a development project for laser lithotripters
- Organization of product approval according to 93/42/EEC
- Creation of technical documentation for international approval (FDA 510(k), STED according to GHTF/IMDRF)
- Gap analysis and improvement/simplification of existing SOPs and work instructions according to Six Sigma
Risk Manager
PARI Pharma GmbH
- Gap analysis of technical documentation for conformity assessment according to MDD (93/42/EEC)
- Creation of a risk management file according to ISO 14971
Regulatory Affairs Specialist
Baxter Europe
- Project management for the integration of quality management for two companies
- Process mapping of SOPs for design control, risk management, and CE approval
- Comparison of SOPs and work instructions according to ISO 13485
- Introduction of life cycle management for medical devices
- Introduction of technical documentation for international approval (MDR, FDA 510(k))
- Employee training
CAPA Specialist
Stryker Berchtold
- Review and moderation of CAPA projects
- Machine qualification
- Process validation (IQ/OQ/PQ)
Interim Quality Manager
REDA Instrumente
- Support during the recertification audit according to ISO 13485 & 93/42/EEC
- Review of the quality management manual
- Preparation of technical documentation according to GHTF/IMDRF (STED), FDA 510(k)
- Introduction of post-market surveillance for product lifecycle management (PLM)
- International registrations (USA, Canada, Brazil, Colombia, Peru, China)
Interim Quality Management Representative
Maquet Cardiopulmonary
- Support in quality management (revising SOPs, etc.)
- Review of the QM system according to FDA compliance and DIN EN ISO 13485
- Leadership and moderation of CAPA projects
- Conducting internal audits
- Training in quality management
- Support for process validations
CAPA Management Expert
Johnson & 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 local branch offices
Post Market Surveillance Specialist
Smith & Nephew Orthopaedics AG
- Introduction of the Post Market Surveillance process (PMS) in line with GMP
- Definition and creation of PMS reports
- Creation of IQ/OQ/PQ plans as part of the relocation of the production site
Quality Manager and Regulatory Affairs Manager
Sopro-Comeg GmbH
- Implementation, execution and maintenance of a QM system in line with MDD, FDA GMP, ISO 13485:2003+A1+A2
- Conducting internal and external audits
- Coordination and execution of actions in the CAPA process
- Building and moderating a risk management system according to ISO 14971
- Product approval in line with legal and standard requirements
- Support of development projects with regard to documentation
Regulatory Affairs Manager
KLS Martin Group
- Creation and updates of Design History Files in line with legal and regulatory requirements
- Implementation of life cycle management for medical devices
- Support in the coordination and planning of regulatory parts of clinical evaluations, PMCF and studies
- Creation of dossiers for FDA 510(k) clearances
- Building a risk management system according to ISO 14971
- Building global Regulatory Affairs Management for the entire group
Quality Manager and Regulatory Affairs
StarMedTec GmbH
- Product approval in line with EU, USA and Asia (93/42/EEC, MDD, FDA GMP)
- Implementation and maintenance of a QM system according to MDD, FDA GMP, ISO 13485:2003+A1+A2
- Conducting internal and external audits
- Coordination of CAPA actions
- Moderation of cross-functional quality-related processes
- Support of development projects
Quality Manager
Pulsion Medical Systems AG
- Implementation, execution and maintenance of a QM system in line with MDD, FDA 21 CFR 820, ISO 13485
- Monitoring the use of quality tools and tests
- Representation toward customers and authorities
- Coordination of complaint handling
- CAPA management
- Head of the quality assurance department
- Process validation and qualification (ISO 10993, IQ/OQ/PQ)
- Cleanroom validation according to ISO 14644
- Introduction of new in-process controls
- Conducting internal and external audits
Headquarter Complaint Manager
Agfa Gevaert AG
- Moderation between internal departments and external interfaces
- Introduction of global Post Market Surveillance processes (complaints, CAPA)
- Streamlining complaint handling between branches and head office
- Preparation of statistics and trend reports on product quality
- Specification and introduction of a global complaints database
- Measurement and monitoring of complaints with reporting
- Training in the CAPA process and complaint system
- Process capability analyses according to Six Sigma (process FMEA, ANOVA, control charts)
- Process improvements in quality management
- Support during the introduction of Computerized Software Validation (CSV)
Product Specialist for 2nd Line Support
Agfa Gevaert AG
- 2nd line support for branches, customers and dealers
- Field service for installations and service
- Conducting system and device trainings
- Development of course content and training materials
- Support with specifications, validation and product launch
- Programming in Unix and Assembler
- Remote diagnosis of device faults via VPN
Product Specialist, Auditor
TÜV Süd Produkt Service
- Coordination of approvals according to FDA 510(k) and in Japan
- Auditor and lead auditor for quality management systems according to ISO 9000/EN 46000, MDD, AIMD
- Expert for regulatory approval of medical devices (extracorporeal circuits)
- Testing the safety of medical electrical devices according to IEC 60601-1
- Testing electromagnetic compatibility according to IEC 60601-1-2
- Member of the committee for CE certification
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Healthcare, Manufacturing, Professional Services, Information Technology, and Pharmaceutical.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Quality Assurance, Business Intelligence, Legal, Product Development, Project Management, and Customer Service.
Skills
Auditor According To Iso 13485
Quality Management According To Iso 13485, Fda 21 Cfr 820 Etc.
Post-Market Surveillance (Complaint Handling, Capa Management, Post-Market Clinical Follow-Up)
Capa Management
Risk Management According To Iso 14971 Over The Entire Product Lifecycle
Cybersecurity (Mdcg 2019/016, Iec 81001-5-1)
Csv (Computerized Software Validation) According To Iec 62304
Usability According To Iec 62366
Safety Of Medical Electrical Equipment According To En Iso 60601-1 As Well As Part 2 Standards Of En 60601
Electromagnetic Compatibility Of Medical Electrical Equipment According To En 60601-1-2
Post-Market Surveillance
Qualification And Validation Of Manufacturing Processes
Product Fmea
Process Fmea
Iq/Oq/Pq
Expertise In Biocompatibility For Medical Devices According To Iso 10993
Knowledge Of Samd (Software As A Medical Device)
Expert Knowledge Of National And International Standards
Technical Documentation According To Annex Ii Of The Mdr (2017/745/Ec)
Fda (510k & Premarket Approval / Pma)
Approval According To Mdr (2017/745/Ec), Fda (510k & Premarket Approval / Pma)
Project Management
Six Sigma Black Belt
Very Good It Skills In Office, Visio, Unix/Linux, Knowledge Of Minitab, Citrix
Former Lecturer At TÜV SüD Akademie For Risk Management According To Iso 14971 And Technical Documentation
Iso 10993, Biocompatibility Of Medical Devices
Iso 5832, Metallic Materials For Surgical Implants
Iso 7153, Metallic Materials For Surgical Instruments
Iec 80001-1, Application Of Risk Management For It Networks With Medical Devices
Iec 81001-5-1, Health Software And Health It Systems Security
Iso/Iec 29147, Information Technology, Security Techniques – Vulnerability Disclosure
Iso 15223-1, Labeling Of Medical Devices
Iso 2859-1, Acceptance Sampling Inspection (Aql)
Iso 13485:2016, Quality Management For Medical Device Manufacturers
Iso 9001:2015, Quality Management In General
Iso 14644, Cleanrooms And Associated Controlled Environments
Iso 17664, Processing Of Medical Devices
Iso 14971 (2012 And 2019 Versions), Risk Management In Medical Technology
Iso/Tr 24971, Guidance On The Application Of Iso 14971
Iec 62304, Medical Device Software - Software Life Cycle Processes (Csv)
Iec/Tr 80002-1, Software For Medical Devices
Iec 62366-1, Application Of Usability To Medical Devices (Usability)
Iso 9241-11, Ergonomics Of Human-System Interaction - Part 11: Usability: Definitions And Concepts
Mdcg 2019-16, Guidance On Cybersecurity For Medical Devices
Mdcg 2019-11, Qualification And Classification Of Software Under Mdr
Team-Nb Position Papers, E.G. On Cybersecurity, Artificial Intelligence In Medical Devices
Sted (Summary Technical Documentation) Of The Ghtf & Toc (Table Of Contents) Of The Imdrf
Mdsap: Medical Device Single Audit Program
Essential Principles Of Safety And Performance Of Medical Devices And Ivd Medical Devices Of The Imdrf
Languages
Education
Ulm University of Applied Sciences
Dipl.-Ing. · Biomedical Engineering · Ulm, Germany
Certifications & licenses
Usability & Requirements with Thomas Geis
Johner Institute
Cybersecurity for Medical Devices and IEC 81001-5-1
Johner Institute
Medical Device Forum, focus on cybersecurity, AI Act, Data Act
TÜV Süd Akademie
Artificial Intelligence (AI) in Medical Technology
TÜV Süd Akademie
TÜV Süd Akademie
Process Validation in the Field of Medical Devices
TÜV Süd Akademie
Advanced Product Quality Planning - APQP
DGQ
Develop Medical Software in Compliance with the Law
Johner Institute
Computerized Systems Validation (CSV)
Johner Institute
Medical Device Days
Johner Institute
Medical Device Single Audit Program (MDSAP)
BSI
Medical Device Regulation (MDR) in Detail
TÜV Süd Akademie
Medical Device Forum (Autumn Update)
TÜV Süd Akademie
Medical Device Forum
TÜV Süd Akademie
Clinical Evaluation of Medical Devices
TÜV Süd Akademie
Approval of Medical Devices in the USA
TÜV Süd Akademie
ISO 13485:2016 - Introduction and Implementation
TÜV Süd Akademie
Technical Documentation for Medical Devices
TÜV Süd Akademie
Train - Present - Teach (Train The Trainer)
IHK Academy
Medical Device Approval in Latin America, Russia, Asia and the Middle East
Forum Institut
Process Optimization
DGQ
Process Validation for Medical Devices
TÜV Süd Akademie
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Andreas is based in Grafing bei München, Germany.
Andreas speaks the following languages: German (Native), English (Advanced).
Andreas has at least 29 years of experience. During this time, Andreas has worked in at least 22 different roles and for 21 different companies. The average length of individual experience is 1 year and 3 months. Note that Andreas may not have shared all experience and actually has more experience.
Based on recent experience, Andreas would be well-suited for roles such as: Consulting on quality management and regulatory affairs, Interim manager for risk management and usability, Project management for process validation.
Andreas's most recent position is Consulting on quality management and regulatory affairs at Curevius GmbH.
In recent years, Andreas has worked for Curevius GmbH, Technolas Perfect Vision GmbH, ITM Medical Isotopes GmbH, and Karl Storz SE & Co. KG.
Andreas is most experienced in industries like Healthcare, Manufacturing, and Professional Services. Andreas also has some experience in Information Technology and Pharmaceutical.
Andreas is most experienced in business areas like Quality Assurance, Business Intelligence, and Legal. Andreas also has some experience in Product Development, Project Management, and Customer Service.
Andreas has recently worked in industries like Healthcare and Pharmaceutical.
Andreas has recently worked in business areas like Quality Assurance, Product Development, and Audit.
Andreas holds a Bachelor in Biomedical Engineering from Ulm University of Applied Sciences.
Andreas has 24 certificates. Among them, these include: Usability & Requirements with Thomas Geis, Cybersecurity for Medical Devices and IEC 81001-5-1, Medical Device Forum, focus on cybersecurity, AI Act, and Data Act.
Andreas is immediately available full-time for suitable projects.
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Calculated based on our freelancers’ daily rates as of 7 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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