Andreas Seidl - Interim Head of Risk Management and Usability

Grafing bei München, Germany

Experience

Mar 2023 - Oct 2024

1 year 8 months

Munich, Germany

Interim Head of Risk Management and Usability

Technolas Perfect Vision GmbH

Lasers for ophthalmology
Creation and maintenance of risk management files for ophthalmology devices
Creation of a cybersecurity risk analysis according to MDCG (Medical Devices Coordination Group for notified bodies oversight, standardisation, market surveillance, international affairs, new technologies or clinical investigations) 2019/016, IEC 81001-5-1
Testing 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

Garching, Germany

Project management for process validation

ITM Medical Isotopes GmbH

Radionuclides for diagnostics and therapy as well as radiopharmaceuticals
Coordination of process validation (URS, pFMEA) for a new production of radioactive drugs
Preparation of approval-relevant validation documentation according to the Medicinal Product Regulation (EU) 2021/228

Jun 2021 - Apr 2022

11 months

Tuttlingen, Germany

Moderator for risk management according to ISO 14971:2019

Karl Storz SE & Co. KG

Class III products such as instruments for neural surgery/HF surgery, endoscopes, bone punches, etc. in the neural area
Risk management according to ISO 14971:2019 for Class III medical devices
Moderation of risk analyses
Revision of the SOP for risk management according to ISO 14971:2019

Sep 2020 - Feb 2021

6 months

Mannheim, Germany

Technical documentation according to Annex II MDR and product establishment

Vibrosonic GmbH

Hearing contact lens / hearing aids
Product approval for clinical studies
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 approval (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

Maisach, Germany

Regulatory Affairs Manager

HMT Medizintechnik

Support for the approval of medical devices
User-specific tubing sets for heart-lung machines
Improvement of the current quality management manual (SOPs, work instructions, etc.)
Gap analysis for product and process validations (process FMEA, DQ/IQ/OQ/PQ)
Building a risk management system according to ISO 14971
Technical documentation according to Annex II of the MDR (2017/745/EU)
Support and coordination for changing 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

Berlin, Germany

Support for medical device approval

aap Implantate

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

Apr 2017 - Dec 2018

1 year 9 months

Munich, Germany

Project management for creating technical documentation

Baxter Europe

Dialysis devices and related disposable items
Restructuring the design control process (SOPs, work instructions)
Project management for creating technical documentation (STED according to GHTF/IMDRF)
Preparation of clinical evaluations according to MEDDEV 2.7.1 Revision 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

Weßling, Germany

Development Project Manager

Dornier MedTec

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

Apr 2016 - Mar 2017

1 year

Munich, Germany

Risk Manager

PARI Pharma GmbH

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

May 2015 - Dec 2015

8 months

Munich, Germany

Regulatory Affairs Specialist

Baxter Europe

Dialysis devices and related disposable items
Project management for integrating the quality management systems of two companies
Process mapping of SOPs for design control, risk management, and CE approval
Alignment of SOPs and work instructions between quality management systems of different organizations/manufacturers according to ISO 13485
Implementation of life cycle management for medical devices
Introduction of technical documentation for international approval for EU MDR (2017/745) and US 510(k) (21 CFR 820)
Employee training
Technical documentation according to GHTF/IMDRF (STED)

Jan 2015 - May 2015

5 months

Tuttlingen, Germany

CAPA Specialist

Stryker Berchtold

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

Apr 2014 - Oct 2014

7 months

Tuttlingen, Germany

Interim Quality Manager

REDA Instrumente

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

Nov 2013 - Mar 2014

5 months

Rastatt, Germany

Interim Quality Management Representative

Maquet Cardiopulmonary

Heart-lung machines
Support in quality management (revising SOPs, etc.)
Review of the QMS for FDA compliance and DIN EN ISO 13485
Leading and moderating CAPA projects
Conducting internal audits
Training in quality management
Managing process validations

Aug 2013 - Nov 2013

4 months

Tuttlingen, Germany

CAPA Management Expert

Johnson und Johnson / Synthes

Endoprosthetics
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 branch sites

May 2013 - Aug 2013

4 months

Aarau, Switzerland

Post Market Surveillance Specialist

Smith & Nephew Orthopaedics AG

Orthopedics, traumatology
Implementation of the post-market surveillance process (PMS) according to GMP
Definition and preparation of PMS reports
Creation of IQ/OQ/PQ plans in connection with the relocation of the production site

Sep 2012 - Apr 2013

8 months

Tuttlingen, Germany

Quality Manager and Regulatory Affairs Manager

Sopro-Comeg GmbH

Endoscopy
Implementation, execution, and maintenance of a QMS according to the requirements of the 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 regulatory requirements
Supporting development projects with documentation in line with legal and regulatory requirements

Jan 2010 - Aug 2012

2 years 8 months

Tuttlingen, Germany

Regulatory Affairs Manager

KLS Martin Group, Karl Leibinger GmbH

Cranial implants, retractors, distractors, surgical instruments, and operating lights
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 the regulatory part of clinical evaluations, PMCF, and studies
Preparing dossiers for FDA 510(k) clearances
Establishing a risk management system according to ISO 14971
Managing an FDA inspection
Redefining and integrating requirements into existing processes
Building a global regulatory affairs management system for the entire KLS Martin Group

Jan 2009 - Jun 2009

6 months

Starnberg, Germany

Quality Manager and Regulatory Affairs

StarMedTec GmbH

Laser lithotripter
Product approval according to legal and regulatory requirements of the EU, USA, and Asia (focus: 93/42/EEC, MDD - FDA GMP 21 CFR 820)
Implementation, execution, and maintenance of a QMS according to the requirements of the MDD, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordinating and executing actions in the CAPA process
Facilitating coordination of cross-departmental quality-related processes
Supporting development projects

Apr 2008 - Dec 2008

9 months

Feldkirchen, Germany

Quality Manager

Pulsion Medical Systems AG

Cardiovascular systems in the critical care area
Implementation, execution, and maintenance of a QMS according to the requirements of 93/42/EEC (MDD), FDA GMP (21 CFR 820), ISO 13485
Monitoring the use of quality tools and related inspections
Representing the company to customers and authorities
Coordinating complaint management
CAPA management
Leading and coordinating the quality assurance department
Process validation and qualification for the production of biocompatible single-use articles according to ISO 10993 (IQ/OQ/PQ)
Cleanroom validation according to ISO 14644
Introducing new in-process controls in manufacturing
Conducting internal and external audits (supplier audits)

Mar 2001 - Mar 2008

7 years 1 month

Munich, Germany

Headquarter Complaint Manager

Agfa Gevaert AG

Healthcare division, computed radiology, PACS (Picture Archiving and Communication System)
Interdisciplinary facilitation of internal departments as well as external interfaces
Implementing global processes for post-market surveillance (complaints, CAPA, etc.), including defining parameters for inputs, outputs, and escalations
Streamlining complaint handling between local subsidiaries and the headquarters
Developing statistics and trend reports to analyze overall product quality
Specifying and implementing a database for global complaint recording
Measuring and monitoring complaints with reporting to cross-departmental teams and management
Training on the CAPA process and use of the complaint system
Analyzing and measuring process capability according to Six Sigma (process FMEA, ANOVA, control charts, etc.)
Improving quality management processes using Six Sigma
Supporting an FDA inspection
Supporting the implementation of Computerized Software Validation (CSV)

Sep 1998 - Mar 2001

2 years 7 months

Munich, Germany

Product Specialist for 2nd Line Support

Agfa Gevaert AG

Healthcare division, computed radiology, PACS (Picture Archiving and Communication System)
2nd line support for Agfa branches, customers and dealers
Field assignments for installations and service calls at customer or dealer sites
Conducting system and equipment training courses for branches, customers and dealers
Developing course content and training materials
Collaborating on specifications, validation and introduction of new products
Programming in Unix, assembler
Remote diagnosis of device faults over the Internet (via VPN)

Sep 1993 - Aug 1998

5 years

Germany

Product Specialist, Auditor

TÜV Süd Product Service

Approval of medical devices, certification of medical device manufacturers
Coordinator for FDA 510(k) submissions
Central coordinator for medical device approvals in Japan
Auditor and lead auditor for the certification of QM systems according to ISO 9000 / EN 46000, MDD and AIMD in Europe, East Asia and the USA
Expert for statutory approval of medical devices (focus on extracorporeal circuits – blood cell separators, dialysis machines, heart-lung machines)
Testing the safety of medical electrical equipment according to IEC 60601-1
Testing electromagnetic compatibility according to IEC 60601-1-2
Member of the certification committee for QM systems

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 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 And 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 Of 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/eu)
Fda (510k & Premarket Approval / Pma)
Approval According To Mdr (2017/745/eu), Fda (510k & Premarket Approval / Pma)
Project Management
Support, Leadership, And Facilitation Of Interdisciplinary Teams
Six Sigma Black Belt
Excellent It Skills In Office, Visio, Unix/linux, And Software Such As Minitab, Citrix
Knowledge Of Alm/plm Systems Such As Polarion
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, Health Software And Health It Systems Safety
Iso/iec 29147, Information Technology, Security Techniques – Vulnerability Disclosure
Iso 15223-1, Labeling Of Medical Devices
Iso 2859-1, Acceptance Sampling (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, 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, Guideline On Cybersecurity For Medical Devices
Mdcg2 2019-11, Qualification And Classification Of Software Under The 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