Andreas Seidl - Interim Head of Risk Management and Usability

Q: Where is Andreas based?

Andreas is based in Grafing bei München, Germany .

Q: What languages does Andreas speak?

Andreas speaks the following languages: German (Native), English (Advanced) .

Q: How many years of experience does Andreas have?

Andreas has at least 28 years of experience. During this time, Andreas has worked in at least 21 different roles and for 20 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.

Q: What is Andreas's latest experience?

Andreas's most recent position is Interim Head of Risk Management and Usability at Technolas Perfect Vision GmbH .

Q: What companies has Andreas worked for in recent years?

In recent years, Andreas has worked for Technolas Perfect Vision GmbH , ITM Medical Isotopes GmbH , Karl Storz SE & Co. KG , and Vibrosonic GmbH .

Q: Which industries is Andreas most experienced in?

Andreas is most experienced in industries like Healthcare , Manufacturing , and Professional Services . Andreas also has some experience in Information Technology (IT) and Pharmaceutical .

Q: Which business areas is Andreas most experienced in?

Andreas is most experienced in business areas like Quality Assurance (QA) , Business Intelligence , and Legal and Compliance . Andreas also has some experience in Product Development , Project Management , and Customer Service .

Q: Which industries has Andreas worked in recently?

Andreas has recently worked in industries like Healthcare and Pharmaceutical .

Q: Which business areas has Andreas worked in recently?

Andreas has recently worked in business areas like Quality Assurance (QA) , Product Development , and Project Management .

Recommended expert

Grafing bei München, Germany

Experience

Mar 2023 - Oct 2024

1 year 8 months

Interim Head of Risk Management and Usability

Technolas Perfect Vision GmbH

Creation and maintenance of risk management files for ophthalmology devices
Creation of a cybersecurity risk analysis 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

May 2022 - Oct 2022

6 months

Project management for process validation

ITM Medical Isotopes GmbH

Coordination of process validation (URS, pFMEA) for a new production of radioactive drugs
Creation of regulatory documentation for validation according to the Medicinal Products Regulation (EU) 2021/228

Jun 2021 - Apr 2022

11 months

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 SOP for risk management according to ISO 14971:2019

Sep 2020 - Feb 2021

6 months

Technical documentation according to Annex II MDR and product implementation

Vibrosonic GmbH

Creation of a Design History File (DHF)
Leading an interdisciplinary team for risk management according to ISO 14971
Creation of technical documentation for national and international approvals (510k, MDR Annex II, STED)
Formative and summative usability evaluation according to IEC 62366
Validation of manufacturing processes (pFMEA, DQ/IQ/OQ/PQ)

Jun 2019 - Apr 2020

11 months

Regulatory Affairs Manager

HMT Medizintechnik

Improvement of the current quality management manual (SOPs, work instructions, etc.)
Gap analysis for product and process validations (Process FMEA, DQ/IQ/OQ/PQ)
Establishment of a risk management system according to ISO 14971
Technical documentation according to Annex II of the MDR (2017/745/EU)
Support and coordination during the change of the notified body for certification according to ISO 13485 and MDR
Establishment of supplier management
Creation of usability files according to IEC 62366

Feb 2019 - May 2019

4 months

Support for medical device approvals

aap Implantate

Creation of a risk management file according to ISO 14971
Technical documentation for osteosynthesis products according to MDR (2017/745/EU), FDA 510(k), etc.
Management of open CAPA projects

Apr 2017 - Dec 2018

1 year 9 months

Project management for technical documentation

Baxter Europe

Restructuring the design control process (SOPs, work instructions)
Preparation of technical documentation (STED according to GHTF/IMDRF)
Creation of clinical evaluations according to MEDDEV 2.7.1 Rev. 4
Training of external staff
Developing a strategy for the transition from MDD (93/42/EEC) to MDR (2017/745/EU)

Jun 2016 - Jan 2017

8 months

Development Project Manager

Dornier MedTec

Leading a development project for laser lithotripters
Organizing product approval under 93/42/EEC
Preparation of technical documentation for international approval (FDA 510(k), STED according to GHTF/IMDRF)
Gap analysis and improvement/streamlining of existing SOPs and work instructions using Six Sigma

Apr 2016 - Mar 2017

1 year

Risk Manager

PARI Pharma GmbH

Gap analysis of technical documentation for conformity assessment under MDD (93/42/EEC)
Creation of a risk management file according to ISO 14971

May 2015 - Dec 2015

8 months

Regulatory Affairs Specialist

Baxter Europe

Project lead for integrating quality management systems of two companies
Process mapping of SOPs for design control, risk management, and CE marking
Alignment of SOPs and work instructions with ISO 13485
Implementation of life cycle management for medical devices
Implementation of technical documentation for international approvals (MDR, FDA 510(k))
Employee training

Jan 2015 - May 2015

5 months

CAPA Specialist

Stryker Berchtold

Review and moderation of CAPA projects
Machine qualification
Process validation (IQ/OQ/PQ)

Apr 2014 - Oct 2014

7 months

Interim Quality Manager

REDA Instrumente

Support for the re-certification audit to ISO 13485 & 93/42/EEC
Review of the quality management manual
Preparation of technical documentation according to GHTF/IMDRF (STED), FDA 510(k)
Implementation of post market surveillance for product lifecycle management (PLM)
International registrations (USA, Canada, Brazil, Colombia, Peru, China)

Nov 2013 - Mar 2014

5 months

Interim Quality Management Representative

Maquet Cardiopulmonary

Support in quality management (revising SOPs, etc.)
Review of the QMS for FDA compliance and DIN EN ISO 13485
Leadership and moderation of CAPA projects
Conducting internal audits
Training in quality management
Management of process validations

Aug 2013 - Nov 2013

4 months

CAPA Management Expert

Johnson & Johnson / Synthes

Review of existing CAPA projects according to FDA 21 CFR 820.100
Preparation of review reports for FDA inspections
Support for ongoing CAPA projects at local branches

May 2013 - Aug 2013

4 months

Post Market Surveillance Specialist

Smith & Nephew Orthopaedics AG

Implementation of the post market surveillance process (PMS) according to GMP
Definition and preparation of PMS reports
Creation of IQ/OQ/PQ plans during the relocation of the production site

Sep 2012 - Apr 2013

8 months

Quality Manager and Regulatory Affairs Manager

Sopro-Comeg GmbH

Implementation, execution and maintenance of a QMS according to MDD, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordinating and executing actions in the CAPA process
Establishing and facilitating a risk management system according to ISO 14971
Product approval according to legal and normative requirements
Supporting development projects with documentation matters

Jan 2010 - Aug 2012

2 years 8 months

Regulatory Affairs Manager

KLS Martin Group

Creating and updating Design History Files in line with legal and regulatory requirements
Implementing life cycle management for medical devices
Supporting coordination and planning of regulatory parts of clinical evaluations, PMCF and studies
Preparing dossiers for FDA 510(k) clearances
Establishing a risk management system according to ISO 14971
Setting up global Regulatory Affairs management for the entire group

Jan 2009 - Jun 2009

6 months

Quality Manager and Regulatory Affairs

StarMedTec GmbH

Product approval for EU, USA and Asia (93/42/EEC, MDD, FDA GMP)
Implementing and maintaining a QMS according to MDD, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordinating CAPA actions
Facilitating cross-departmental quality processes
Supporting development projects

Apr 2008 - Dec 2008

9 months

Quality Manager

Pulsion Medical Systems AG

Implementing, executing and maintaining a QMS according to MDD, FDA 21 CFR 820, ISO 13485
Monitoring the use of quality tools and inspections
Representing the company to customers and authorities
Coordinating complaint handling
CAPA management
Leading the quality assurance department
Process validation and qualification (ISO 10993, IQ/OQ/PQ)
Cleanroom validation according to ISO 14644
Introducing new in-process controls
Conducting internal and external audits

Mar 2001 - Mar 2008

7 years 1 month

Headquarter Complaint Manager

Agfa Gevaert AG

Facilitating between internal departments and external interfaces
Implementing global post-market surveillance processes (complaints, CAPA)
Streamlining complaint handling between branches and headquarters
Preparing statistics and trend reports on product quality
Specifying and implementing a global complaint database
Measuring and monitoring complaints with reporting
Training in the CAPA process and complaint system
Performing process capability analyses according to Six Sigma (process FMEA, ANOVA, control charts)
Implementing process improvements in quality management
Supporting the introduction of computerized software validation (CSV)

Sep 1998 - Mar 2001

2 years 7 months

Product Specialist for 2nd Line Support

Agfa Gevaert AG

2nd line support for branches, customers and dealers
Field service for installations and service
Conduct system and device training
Develop course content and training materials
Contribute to specifications, validation and product launch
Programming in Unix and assembler
Remote diagnosis of device failures via VPN

Sep 1993 - Aug 1998

5 years

Product Specialist, Auditor

TÜV Süd Produkt Service

Coordination of approvals under FDA 510(k) and in Japan
Auditor and lead auditor for quality management systems according to ISO 9000/EN 46000, MDD, AIMD
Expert for statutory approval of medical devices (extracorporeal circuits)
Testing safety of medical electrical devices according to IEC 60601-1
Testing electromagnetic compatibility according to IEC 60601-1-2
Member of the CE certification committee

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 Across The 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 And The 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)
Expertise In National And International Standards
Technical Documentation According To Annex Ii Of The Mdr (2017/745/eu)
Fda (510k & Premarket Approval / Pma)
Approval According To Mdr (2017/745/eu), Fda (510k & Premarket Approval / Pma)
Project Management
Six Sigma Black Belt
Strong It Skills In Office, Visio, Unix/linux, Knowledge Of Minitab, Citrix
Former Lecturer At Tüv Süd Academy 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, Safety Of Health Software And Health It Systems
Iso/iec 29147, Information Technology - Security Techniques - Vulnerability Disclosure
Iso 15223-1, Labelling Of Medical Devices
Iso 2859-1, Acceptance Sampling Procedures (Aql)
Iso 13485:2016, Quality Management For Medical Device Manufacturers
Iso 9001:2015, General Quality Management
Iso 14644, Cleanrooms And Associated Controlled Environments
Iso 17664, Processing Of Medical Devices
Iso 14971 (Versions 2012 And 2019), 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, Medical Device Software
Iec 62366-1, Application Of Usability To Medical Devices
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 According To The Mdr
Team-nb Position Papers, E.g., On Cybersecurity, Artificial Intelligence In Medical Devices
Sted (Summary Technical Documentation) By Ghtf & Toc (Table Of Contents) By Imdrf
Mdsap: Medical Device Single Audit Program
Essential Principles Of Safety And Performance Of Medical Devices And Ivd Medical Devices By Imdrf

Languages

German

Native

English

Advanced

Education

Hochschule Ulm

Diploma Engineer · Biomedical Engineering · Ulm, Germany

Certifications & licenses

Usability & Requirements with Thomas Geis

Johner Institut

Cybersecurity for Medical Devices and IEC 81001-5-1

Johner Institut

Medical Device Forum, focus on Cybersecurity, AI Act, Data Act

TÜV Süd Akademie

Artificial Intelligence (AI) in Medical Technology

TÜV Süd Akademie

Risk Management within ISO 9001:2015

TÜV Süd Akademie

Process Validation in Medical Devices

TÜV Süd Akademie

Advanced Product Quality Planning - APQP

DGQ

Developing medical software in compliance with regulations

Johner Institut

Computerized Systems Validation (CSV)

Johner Institut

Medical Device Days

Johner Institut

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

Training - Presenting - Teaching (Train The Trainer)

Ihk-Akademie

Risk Management and Risk Analysis for Medical Devices according to DIN EN ISO 14971:2012

TÜV Süd Akademie

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

Profile

Created

April 2025

Last Update

May 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Andreas based?

Andreas is based in Grafing bei München, Germany.

What languages does Andreas speak?

Andreas speaks the following languages: German (Native), English (Advanced).

How many years of experience does Andreas have?

Andreas has at least 28 years of experience. During this time, Andreas has worked in at least 21 different roles and for 20 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.

What roles would Andreas be best suited for?

Based on recent experience, Andreas would be well-suited for roles such as: Interim Head of Risk Management and Usability, Project management for process validation, Moderator for risk management according to ISO 14971:2019.

What is Andreas's latest experience?

Andreas's most recent position is Interim Head of Risk Management and Usability at Technolas Perfect Vision GmbH.

What companies has Andreas worked for in recent years?

In recent years, Andreas has worked for Technolas Perfect Vision GmbH, ITM Medical Isotopes GmbH, Karl Storz SE & Co. KG, and Vibrosonic GmbH.

Which industries is Andreas most experienced in?

Andreas is most experienced in industries like Healthcare, Manufacturing, and Professional Services. Andreas also has some experience in Information Technology (IT) and Pharmaceutical.

Which business areas is Andreas most experienced in?

Andreas is most experienced in business areas like Quality Assurance (QA), Business Intelligence, and Legal and Compliance. Andreas also has some experience in Product Development, Project Management, and Customer Service.

Which industries has Andreas worked in recently?

Andreas has recently worked in industries like Healthcare and Pharmaceutical.

Which business areas has Andreas worked in recently?

Andreas has recently worked in business areas like Quality Assurance (QA), Product Development, and Project Management.

What is Andreas's education?

Andreas holds a Bachelor in Biomedical Engineering from Hochschule Ulm.

Does Andreas have any certificates?

Andreas has 23 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.

What is the availability of Andreas?

Andreas is immediately available full-time for suitable projects.

What is the rate of Andreas?

Andreas's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.