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

Languages

German
Native
English
Advanced

Education

Hochschule Ulm

Diploma Engineer · Biomedical Engineering · Ulm, Germany

Certifications & licenses

ISO 13485 auditor

Six Sigma Black Belt project management

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