Andreas Seidl

Interim Head for Risk Management and Usability

Grafing bei München, Germany

Experience

Mar 2023 - Oct 2024
1 year 8 months
Munich, Germany

Interim Head for Risk Management and Usability

Technolas Perfect Vision GmbH

  • Creation and maintenance of risk management files
  • Conducting usability studies
  • Process validation
  • Support of quality management, among others in maintaining processes for risk management, usability, design control, and CAPA management
May 2022 - Oct 2022
6 months
Garching, Germany

Project Management for Process Validation

ITM Medical Isotopes GmbH

  • Coordination of process validation for a new manufacturing of radioactive drugs
  • Preparation of approval-relevant validation documentation
Jun 2021 - Apr 2022
11 months
Tuttlingen, Germany

Moderator for Risk Management according to ISO 14971:2019

Karl Storz SE & Co. KG

  • Risk management for Class III medical devices
  • Moderation of risk analyses
  • Revision of risk management processes according to ISO 14971:2019
  • General support in risk management
Sep 2020 - Feb 2021
6 months
Mannheim, Germany

Support for the Creation and Implementation of Technical Documentation as well as the Establishment of Production

Vibrosonic GmbH, Mannheim

  • Product approval for clinical trials
  • Creation of a DHF
  • Risk management in coordination with QM, RA, CA, Labeling, R&D, RM, Purchasing
  • Preparation of technical documentation for national and international approvals
  • Formative and summative usability evaluation
  • Validation of manufacturing processes
Jun 2019 - Apr 2020
11 months
Maisach, Germany

Support for Medical Device Approval

HMT Medizintechnik

  • Regulatory Affairs Manager
  • Improvement of the current quality management
  • Gap analysis of the QM manual
  • Gap analysis for product and process validations
  • Establishment of a risk management system according to ISO 14971
  • Technical documentation according to Annex II of the MDR
  • Support and coordination for the switch of the Notified Body
  • Establishment of supplier management according to MDR
  • Preparation of usability files according to IEC 62366
Feb 2019 - May 2019
4 months
Berlin, Germany

Support for Medical Device Approval / Head of Technical Documentation

aap Implantate

  • Creation of a risk management file
  • Technical documentation for osteosynthesis instruments
  • Maintenance of open CAPA projects
Apr 2017 - Dec 2019
1 year 9 months
Munich, Germany

Project Management for the Creation of Technical Documentation

Baxter Europe

  • Restructuring of design control
  • Project management for the creation of technical documentation
  • Preparation of clinical evaluations according to MEDDEV 2.7.1 Rev. 4
  • Training of external staff
  • Development of a strategy for the transfer from MDD to MDR
Jun 2016 - Jan 2017
8 months
Weßling, Germany

Development Project Manager

Dornier MedTec

  • Management of a development project
  • Organization of product approval
  • Preparation of technical documentation for international approvals (MDR, 510(k), etc.)
  • GAP analysis and improvement/streamlining of existing processes (design control, risk management, post-market surveillance, technical documentation)
  • GAP analysis and correction of technical documentation
Apr 2016 - Mar 2017
1 year
Munich, Germany

Risk Manager

PARI Pharma GmbH

  • Gap analysis of technical documentation for conformity assessment
  • Risk management review
May 2015 - Dec 2015
8 months
Munich, Germany

Regulatory Affairs Specialist

Baxter Europe, München

  • Project management for the merger of the quality management of two companies
  • Process mapping for design control, risk management and CE approval
  • Process alignment between quality management systems of different organizations/manufacturers
  • Introduction of a life-cycle management for conformity assessment to the MDD
  • Introduction of technical documentation for international approval under the MDR (= 2017/745) of the EU and 510(k) for the USA (= 21 CFR 820)
  • Staff training
  • Preparation of so-called STEDs according to GHTF guidelines
Jan 2015 - May 2015
5 months
Tuttlingen, Germany

CAPA Specialist

Stryker Berchtold

  • Review and moderation of CAPA projects
  • Equipment qualification
  • Process validation (IQ/OQ/PQ)
Apr 2014 - Oct 2014
7 months
Tuttlingen, Germany

Interim Quality Manager

REDA Instrumente

  • Support during the re-certification audit
  • Review of the complete quality management system
  • Preparation of technical documentation
  • Introduction of post-market surveillance for PLM without involvement of the OEM
  • International registration (USA, Canada, Brazil, Colombia, Peru, China)
Nov 2013 - Mar 2014
5 months
Rastatt, Germany

Interim Quality Management Representative

Maquet Cardiopulmonary

  • Support in the area of quality management
  • Review of the QM system for FDA compliance and DIN EN ISO 13485
  • Management and moderation of CAPA projects
  • Conducting internal audits
  • Training in quality management
  • Supervision of process validations
Aug 2013 - Nov 2013
4 months
Tuttlingen, Germany

CAPA Management Expert

Johnson und 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 branch sites
May 2013 - Aug 2013
4 months
Aarau, Switzerland

Post Market Surveillance Specialist

Smith & Nephew Orthopaedics AG

  • Introduction of the post-market surveillance process (PMS)
  • Definition and preparation of reports within PMS
  • Preparation of IQ/OQ/PQ plans in the course of relocation of the production facility
Sep 2012 - Apr 2013
8 months
Tuttlingen, Germany

Quality Manager and Regulatory Affairs

Sopro-Comeg GmbH

  • Implementation, execution and maintenance of a QM system according to the requirements of the MDD, FDA GMP, ISO 13485:2003+A1+A2
  • Conducting internal and external audits
  • Coordination and execution of actions in the CAPA process
  • Establishment and moderation of a risk management system according to ISO 14971
  • Product approval according to legal and normative requirements
  • Support of development projects in documentation issues according to legal and normative requirements
Jan 2009 - Aug 2012
2 years 8 months
Tuttlingen, Germany

Regulatory Affairs Manager

KLS Martin Group

  • Creation and updates of Design History Files according to legal and regulatory requirements
  • Implementation of legal and normative requirements over the life cycle of a product
  • 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
  • Improvement of requirements in existing processes
  • Establishment of a regulatory affairs management for the entire KLS Martin Group
Jan 2009 - Jun 2009
6 months
Starnberg, Germany

Quality Manager

StarMedTec GmbH

  • Coordination of product approvals for the EU, USA and Asia
  • Implementation, execution and maintenance of a QM system according to the requirements of the MDD, FDA GMP, ISO 13485:2003+A1+A2
  • Conducting internal and external audits
  • Coordination and execution of actions in the CAPA process
  • Moderation of cross-departmental quality relevant processes
  • Product approval according to legal and normative requirements
  • Support of development projects
Apr 2008 - Dec 2009
9 months
Munich, Germany

Quality Manager

Pulsion Medical Systems AG, München

  • Implementation, execution and maintenance of a QM system according to the requirements of the MDD, FDA GMP, ISO 13485:2003+A1+A2
  • Monitoring the application of employed quality tools and associated tests
  • Representation of the company towards customers and authorities
  • Coordination of complaint management
  • Coordination and execution of actions in the CAPA process
  • Leadership and coordination of the quality assurance department
  • Process validation and qualification for production (IQ/OQ/PQ)
  • Introduction of new in-process controls in manufacturing
  • Conducting internal system and external supplier audits
Mar 2001 - Mar 2008
7 years 1 month
Munich, Germany

Headquarter Complaint Manager

Agfa Gevaert AG

  • Moderation among internal departments as well as with external interfaces
  • Introduction of global processes for post-market surveillance (complaints, CAPA etc.)
  • Development of statistics and trend reports on product quality
  • Specification and introduction of a complaint database
  • Monitoring of complaints recorded in the database with reporting to cross-departmental teams and management
  • Execution of projects to improve product monitoring
  • Training on the CAPA process and use of the complaint system
  • Improvement of QM management processes according to Six Sigma
  • Introduction of computerized software validation (CSV)
Sep 1998 - Jan 2001
2 years 5 months
Munich, Germany

Product Specialist

Agfa Gevaert AG

  • 2nd line support for Agfa branches, customers and dealers
  • Field service for installations and service calls at customers or dealers
  • Conducting system and device courses
  • Participation in specifications, validation and introduction of new products
Sep 1993 - Aug 1998
5 years
Munich, Germany

Product Specialist

TÜV Product Service GmbH

  • Coordinator for FDA 510(k) approvals
  • Central coordinator for the approval of medical devices in Japan
  • Auditor and lead auditor for the acceptance of QM systems according to ISO 9000 / EN 46000, MDD and AIMD in Europe, East Asia and the USA
  • Expert for the regulatory approval of medical devices
  • Member of the committee for CE certification

Languages

German
Native
English
Advanced

Education

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Diploma · Medical Engineering · Ulm, Germany

Certifications & licenses

Cybersecurity for Medical Devices and IEC 81001-5-1

Artificial Intelligence (AI) in Medical Engineering

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

Risk Management within the scope of ISO 9001:2015

Advanced Product Quality Planning – APQP

Process Validation in the Field of Medical Devices

Computerized Systems Validation (CSV)

Developing Medical Software in Compliance with Regulations

Medical Device Single Audit Program (MDSAP)