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 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

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 manufacturing line of radioactive drugs
Preparation of regulatory validation documentation according to the Medicinal Products Regulation (EU) 2021/228

Jun 2021 - Apr 2022

11 months

Tuttlingen, Germany

Facilitator for Risk Management according to ISO 14971:2019

Karl Storz SE & Co. KG

Class III surgical instruments
Risk management according to ISO 14971:2019 for Class III medical devices
Facilitation 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 Introduction

Vibrosonic GmbH

Hearing contact lens
Product approval for clinical trials
Creation of a Design History File (DHF)
Leading an interdisciplinary team for risk management according to ISO 14971
Preparation 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

Maisach, Germany

Support for Medical Device Approval, Regulatory Affairs Manager

HMT Medizintechnik

Custom 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)
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 in the transition to a new notified body for ISO 13485 and MDR certification
Development of a supplier management system
Preparation of usability files according to IEC 62366

Feb 2019 - May 2019

4 months

Berlin, Germany

Support for Medical Device Approval

aap Implantate

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

Apr 2017 - Dec 2019

1 year 9 months

Munich, Germany

Project Management for Technical Documentation

Baxter Europe

Dialysis machines and related single-use items
Restructuring of the design control process (SOPs, work instructions)
Project management for the creation of technical documentation (STED according to GHTF/IMDRF)
Preparation 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

Weßling, Germany

Development Project Manager

Dornier MedTec

Laser lithotripters
Management of a development project
Organization of product approval according to 93/42/EEC
Creation of technical documentation for international approvals (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 for preterm infants
Gap analysis of technical documentation for conformity assessment according to MDD (93/42/EEC)
Preparation of a risk management file according to ISO 14971

May 2015 - Dec 2015

8 months

Munich, Germany

Regulatory Affairs Specialist

Baxter Europe

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

Jan 2015 - May 2015

5 months

Tuttlingen, Germany

CAPA Specialist

Stryker Berchtold

Surgical lights
Review and facilitation of CAPA projects
Equipment qualification
Process validation (IQ/OQ/PQ)

Apr 2014 - Oct 2014

7 months

Tuttlingen, Germany

Interim Quality Manager

REDA Instrumente

Surgical instruments
Support during re-certification 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 510(k), etc.
Introduction 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 Officer

Maquet Cardiopulmonary

Heart-lung machines
Support in quality management (revision of SOPs, etc.)
Review of the QMS for FDA compliance and DIN EN ISO 13485
Leadership and facilitation of CAPA projects
Conducting internal audits
Training in quality management
Oversight of 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 in branch locations on site

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 reports in PMS
Development of IQ/OQ/PQ plans as part of production site relocation

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 MDD requirements, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordination and execution of actions in the CAPA process
Establishment and facilitation of a risk management system according to ISO 14971
Product approval according to legal and regulatory requirements
Support of development projects in documentation according to legal and regulatory requirements

Jan 2009 - Aug 2012

2 years 8 months

Tuttlingen, Germany

Regulatory Affairs Manager

KLS Martin Group, Karl Leibinger GmbH

Cranial implants, retractors, distractors, surgical instruments, surgical lights
Creation and updates of Design History Files according to legal and regulatory requirements
Implementation of lifecycle management for medical products
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
Redefinition and integration of requirements into existing processes
Development of 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 lithotripters
Product approval according to legal and regulatory requirements of the EU, USA and Asia (focus: 93/42/EEC, MDD – 21 CFR 820 FDA GMP)
Implementation, execution, and maintenance of a QMS according to MDD requirements, FDA GMP, ISO 13485:2003+A1+A2
Conducting internal and external audits
Coordination and execution of CAPA actions
Facilitation of cross-functional quality-related process alignments
Support of development projects

Apr 2008 - Dec 2009

9 months

Feldkirchen, Germany

Quality Manager

Pulsion Medical Systems AG

Cardio-circulatory systems in critical care
Implementation, execution, and maintenance of a QMS according to 93/42/EEC (MDD), FDA GMP (21 CFR 820), ISO 13485
Monitoring the application of quality tools and related tests
Representation of the company to customers and authorities
Coordination of the complaint management system
CAPA management
Management and coordination of the quality assurance department
Process validation and qualification for production of biocompatible single-use items according to ISO 10993 (IQ/OQ/PQ)
Cleanroom validation according to ISO 14644
Introduction of 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, Bereich Healthcare

Computed radiology, PACS (Picture Archiving and Communication System)
Facilitation among internal departments as well as with external interfaces
Introduction of global post-market surveillance processes (complaints, CAPA, etc.), including definition of parameters for inputs, outputs, and escalations
Streamlining complaint handling between local branches and headquarters
Development of statistics and trend reports for overall product quality analysis
Specification and implementation of a database for global complaint tracking
Measurement and monitoring of complaints with reporting to cross-department teams and management
Training on the CAPA process and the use of the complaint system
Analysis and measurement of process capability according to Six Sigma (Process FMEA, ANOVA, control charts, etc.)
Improvement of QMS processes using Six Sigma
Support for the introduction of computerized software validation (CSV)

Sep 1998 - Mar 2001

2 years 7 months

Munich, Germany

Product Specialist for 2nd Line Support

Agfa Gevaert AG, Bereich Healthcare

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

Sep 1993 - Aug 1998

5 years

Germany

Product Specialist, Auditor

TÜV Süd Produkt Service

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

Summary

ISO 13485 auditor
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 the Part 2 standards of EN 60601
Electromagnetic compatibility of medical electrical equipment according to EN 60601-1-2
Qualification and validation of manufacturing processes
Product FMEA
Process FMEA
IQ/OQ/PQ
Expert knowledge of 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)
Regulatory approval according to MDR (2017/745/EU), 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 Academy for risk management according to ISO 14971 and technical documentation