Andreas S.
Interim Head of Risk Management and Usability
Experience
Mar 2023 - Oct 2024
1 year 8 monthsMunich, 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 monthsGarching, 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 monthsTuttlingen, 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 monthsMannheim, 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 monthsMaisach, 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 monthsBerlin, 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 2018
1 year 9 monthsMunich, 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 monthsWeßling, 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 yearMunich, 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 monthsMunich, 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 monthsTuttlingen, 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 monthsTuttlingen, 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 monthsRastatt, 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 monthsTuttlingen, 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 monthsAarau, 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 monthsTuttlingen, 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 2010 - Aug 2012
2 years 8 monthsTuttlingen, 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 monthsStarnberg, 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 2008
9 monthsFeldkirchen, 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 monthMunich, 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 monthsMunich, 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 yearsGermany
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
NativeEnglish
AdvancedEducation
Hochschule Ulm
Diploma Engineer · Biomedical Engineering · Ulm, Germany
Certifications & licenses
ISO 13485 auditor
Six Sigma Black Belt project management
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