• > 20 years in medical device industry
• > 10 years biomechanical testing
• 8 years operative management of biomechanical test site incl. employees
• > 10 internal audits ISO 13485
• Lecturer at SAQ Qualicon, Olten “Quality management in medical technology”, lectures document control and traceability

• Clean room conception and validation in Europe and China
• Qualification and validation of production equipment and processes
• Validation of surface treatment and cleaning processes
• Qualification of measuring methods (MSA)
• Process capability studies
• External management of quality management systems according to ISO 13485
• Internal audits according to ISO 13485 of entire companies including the development process in German and English
• Planning, installing and running a biomechanical test site

• Tribology of artificial joints (hip, knee, shoulder)
• Measurement techniques: CMM (tactile), roughness (non-tactile), microscopy
• General fatigue testing of class III products (servo-hydraulic load frames, specific ISO 7206-2/4/6/8 and ISO 14243
• Abrasive wear testing and calculation
• Quality Assurance (Qualification, Validation, GxP)
• Qualification and validation of equipment, production and measuring processes
• Quality Management System documentations according ISO 13485 and FDA
• Materials (metals and plastics)
• Knowledge of the Chinese culture and basics in Chinese language (HSK II)

• >10 years in medical device industry
• Head of quality management in medical engineering, metal and cosmetics industry
• Establishment and management of a testing lab for polymer technology
• Optimisation of equipment, processes and methods

• Installing, running and optimising of quality management systems ISO 9001 + ISO 13485
• Key position in developing medical devices of classes I, IIa + IIb
• Experience in medical device field, especially in dental (composites) and orthopedics (spine & trauma)
• Process optimization in polymer-, coating- and cleaning techniques in polymer and metal industry
• Implementation and evaluation of CAQ systems
• Implementation of CAQ software (Babteq)
• CAPA management
• Planning and executing of trainings in hygiene and concepts

• Medical device field
• Polymer technology (thermoplasts, impact extrusion)
• Damage and failure analysis polymer parts
• Metal industry (processing of aluminium, impact extrusion)
• Planning and optimising manufacturing and cleaning processes
• Audit according to ISO 9001, ISO 13485, ISO 14001
• Clean room monitoring

• >10 years of experience in the medical device industry in various positions (quality management, quality engineering, R&D, laboratory)
• 2 years of management responsibility in quality engineering in the medical device industry
• Several years of experience for internal audits as a lead auditor

• Responsible for change and deviation management including processing of deviations, root cause analysis, corrections / corrective actions and CAPAs
• Coordination and approval of qualifications and validations as well as statistical analyses and evaluations of IQ / OQ / PQ / Gage R&R
• Adapting and processing risk analyses / FMEAs for various medical devices and in-vitro diagnostic products
• Inspection and approval of various devices and measuring equipment for production after calibration / repair / OOT (out of tolerance)
• Internal and supplier audits in accordance with ISO 9001, ISO 13485, MepV incl. GPA
• Establish, maintain and optimize QM systems according to ISO 9001, ISO 13485 and QuaTheDa / SODK Ost+
• Supervision of certification audits
• Conduct training courses on various medical device topics

• Medical devices (heart valves, breast pumps, ventilators, insulin pumps, cardiac support systems) and combination products (syringes, autoinjectors)
• Production of liquid / solid culture media / reagents and inoculation of manufactured culture media and reagents with control strains for quality control purposes
• Various hygiene tests such as impression tests, water and air bacteria count (preparing / reading cultures and gram preparations) and stool samples
• Sterilization processes (reception / decontamination / packaging / sterilization)
• Quality management according to ISO 13485; qualification / validation, changes, CAPA, deviations, development / design, document control, procurement
• Gap analyses and risk analyses in various areas
• Auditing of QM systems, processes and suppliers in the areas of ISO 9001, ISO 13485, GPA, MepV, QuaTheDa, SODK Ost+
• Measurement system analyses (Gage R&R) and process validations (IQ / OQ / PQ)

• > 15 years of in different positions within the medical device field
• > 10 years in biomechanical- and structural testing
• > 8 years quality management systems for test laboratories (ISO 17025) in the medical device field as well as integration into overarching QMS systems (ISO 13485)
• > 8 years of applied research in the field of biomechanics
• 4 years in management and leadership within biomechanical testing and applied research

• Medical device clearance submissions at the US/FDA (510(k), Q-Subs, etc.)
• Development, installation and qualification of test for medical device testing in accordance to ISO 17025 requirements
• International transfer of test laboratories including all aspects of quality managment (re-Qualification/Validation, process optimizations, etc. following ISO 17025 requirements and integration into ISO 13485 environment
• Development of clinically relevant test methods for the proof of safety and effectiveness of medical devices for international regulatory clearance
• Development of processes for medical device verification and integration into R&D and life cycle management
• Remediation projects in risk management (ISO 14971) and MDR
• Product development of medical devices (surgical instruments, hip/knee arthroplasty and spine)
• Qualification of test laboratories and corresponding infrastructure
• teaching, mentoring and coaching in the field of device and material testing, biomechanical engineering and diploma thesis

• Medical device clearance in the USA, European Union and Switzerland
• Technical documentation according to ANNEX II of the MDR
• Medical devices: Orthopeadics (Hip, Knee), Spine, Dental
• Mechanical engineering
• Medical device testing (ISO 14801, ASTM F1717, etc.) for international regulatory clearance
• Development of clinically relevant test methods
• Medical device development (V-model, FDA Design Control)
• Applied research in medical devices
• Development and installation of test laboratories and corresponding quality management systems (ISO 17025)
• Documentation within the development process of medical devices, especially product verification and proof of safety and effectiveness

• >15 Jahre in der Medizintechnik und Packmittelherstellung
• Head of Regulatory Affairs & Compliance (6 Jahre) und Head of Quality Management (11 Jahre) für einen Lohnverpacker von Medizinprodukten und Arzneimittel (ISO, FDA, GMP)
• Fachverantwortliche Person (FvP)
• Managementbeauftragter der Geschäftsleitung (QMB)
• Über 100 interne und externe Audits (ISO 9001, 13485 and FDA)

• >15 Jahre in der Medizintechnik und Packmittelherstellung
• Head of Quality, Regulatory Affairs & Compliance (16 Jahre) für einen Lohnverpacker von Medizinprodukten und Arzneimittel (ISO, FDA, GMP)
• Fachverantwortliche Person (FvP)
• Managementbeauftragter der Geschäftsleitung (QMB)
• Über 100 interne und externe Audits (ISO 9001, 13485 and FDA)

• Medizinprodukte und die entsprechenden Verpackungslösungen inklusive Sterilisation
• Qualitätsmanagement- und Produktionsprozesse
• Qualitätskontrolle und Verpackungsvalidierungen
• Auditierung (QM-System, Prozesse und Lieferanten)
• Verantwortliche Person für die Organisation, Durchführung und Nachbearbeitung von FDA-Insektionen
• Commercial Pilot Lizenz (CPL) und Instrument rating (IR)
• Theorieinstruktor für Privatpiloten

• > 15 years in quality management of medical device industry
• > 8 years at a market authorization holder of medical devices in the area of complaint management and vigilance
• 3 years as quality representative at a contract manufacturer for pharmaceutical, medical device and in-vitro-diagnostic companies
• > 7 years management responsibility in different positions within quality (max. 26 employees)
• 2 years part of management team of a company with more than 100 employees

• Successful design and implementation of quality processes using different quality management softwares (incl. CAQ, TrackWise, Pilgrim, SAP QIM)
• Establish, maintain and optimize QM-systems according to ISO 9001 / EN 9100 and ISO 13485, 21CFR820 (FDA), MedDO incl. Good practice for the reprocessing of medical devices (GPA), Directive 93/42 EWG (MDD), Regulation 217/745 (MDR)
• Complaint management, reporting to and communication with competent authorities
• International, multi-site optimization projects for the complaint handling, CAPA, change process
• FDA readiness, preparation for and translation at more than 6 FDA inspections
• >100 internal and supplier audits according to ISO 9001, ISO 13485, MedDO incl. GPA and 21CFR820 (FDA requirements)
• Training on various topics (ISO 13485, 21CFR820, MedDO incl. GPA)

• Medical devices (orthopedic and traumatological implants and instruments, therapeutic devices, etc.)
• Combination products (inhalers, autoinjectors)
• In-vitro-diagnostic products (cuvettes, vials, consumables)
• Materials (metals and polymers)
• Development, optimization and maintenance of quality management systems at medical device manufacturers, suppliers and healthcare facilities (reprocessing, maintenance, materiovigilance and procurement of medical devices)
• Complaint handling / root cause analysis / communication with competent authorities
• Quality management processes e.g. change control, document control, nonconformity, CAPA, management review
• System (QMS), process and supplier audits
• Support for authority inspections (FDA, Swissmedic)

• In total 17 years in the international pharmaceutical / MedTech industry in various roles
• 6 years as a consultant for Axxos AG
• 5 years as a Commercial Pilot in very remote areas (Australia, US) for a NGO.

• Implementation of process validation concepts in MedTech companies with up to 1000 employees
• Quality assurance of development projects regarding technical files, design verification, development of manufacturing process and process validation
• Development and Implementation of QM-Systems according EN 13485 up to successful certification within 3-6 months.
• Lecturing on various topics (Document control and traceability)
• Developing and managing processes and tools for the services of an Swiss- and EU Authorized Representative, including customer relationship management
• Internal auditing according ISO 13485 and support companies during (re-)certification audits

• Quality management (with focus on Validation, Quality Control, Regulatory Affairs, Vigilance and CAPA)
• Manufacturing processes, especially aseptic / biotechnological and plastic moulding processes
• Quality assurance, statistics, sampling and data analysis
• Lean Management
• Occupational Health and Safety for small to medium companies
• Spontaneous projects to achieve and/or maintain compliance
• Lead and coach change management processes
• Coding (R (statistics), Python, Excel, VBA)
• Installation, configuration and use of cloud-based software tools, e.g. of ERP and CRM-Systems, Document Control, Issue Tracking Tools, Websites
• Good knowledge of Linux, Libreoffice, Open Source projects, GIT
• Take off and land aircrafts (single engine piston) on short runways with up to 20% slope

• Over 7 years’ experience in medical device industry in varioous job roles
• Over 10 years’ experience in quality management in various positions and industries
• Over 3 years’ managerial experience in variuous job roles
• Responcible for quality management and regulatory compliance of medical devices for over 4 yeras (ISO, FDA)
• Over 4 years’ experience as a quality engineer working with medical devices and in the automotive, aviation, space and defence industry
• Over 5 years’ experience in production
• Lead auditor for internal and external audits (ISO 13485, FDA and AIAG 16949)

• Development and maintenance of QM-systems according ISO 9001 / 13485, MDD/MDR,  21CFR820 (FDA), part 11 (FDA)
• Successful certification and recertification with various companies
• Establish and implement validation concepts in MedTech and automotive companies
• Audit and inspection readiness, compliance and guidance through NB Audits and FDA investigations
• Internal and supplier auditing according ISO 9001, ISO 13485, FDA, and AIAG 16949 requirements
• Implementation and maintenance of CAQ Systems incl. software validation
• Computer system validation according part11 (FDA)
• Implementation of Best Practices in CAPA, deviation management, audit and Inspection

• Quality management practices
• Validation of equipment, production, inspection processes
• Computer software validation according GAMP 5
• Pre and post audit activities in conjunction with notifed body audits and FDA inspections
• Expert in manufacturing process
• Quality system, process and supplier auditing
• Intercultural communication

• 7 years in medical device industry (dental implants und heart valves)
• 3 years of verification and biomechanical research including laboratory practice
• 3 years of post-market surveillance and field actions
• 2 years clinical evaluation according to MEDDEV 2.7/1 revision 4 and EU2017/745 (MDR)
• Risk management for medical devices utilizing animal tissues and their derivatives
• Laws and standards relevant to the medical device industry
• Lecturer for clinical evaluation at SAQ Qualicon (www.saq-qualicon.com)

• Verification strategy and worst case definition of dental implants
• Update of post-market surveillance processes according to MDR
• Implementation of threshold values and trend evaluation based on statistical analysis for post-market surveillance
• Improvement of risk management for medical devices (dental implants and heart valves)
• Delivering In-house trainings
• Clinical evaluation according to MEDDEV 2.7/1 revision 4 and EU 2017/745 (MDR)
• Process owner of the Axxos update service for laws and standards

• Verification of safety and efficacy of medical devices
• Post-market surveillance of medical devices including trend evaluation and coordination of field actions
• Development and implementation of Standard Operating Procedures (SOP) in a highly regulated environment
• Systematic scientific literature search and evaluation
• Risk management according to ISO 14971
• Laboratory practice (wet lab and biomechanical laboratory)
• Knowledge of medical devices and their requirements (dental implants, heart valves and general orthopedic applications)
• Clinical evaluation according to MEDDEV 2.7/1 revision 4 and EU 2017/745 (MDR)

• > 5 years top management of a company with more than 100 employees
• > 20 years management responsibility in different positions
• > 25 years quality management responsibility medical devices (ISO, GMP)
• > 10 years production skills
• > 5 years development and construction experience
• 5 years in a human resources manager position
• More than 200 internal and external audits as lead auditor (ISO 13485 and FDA)

Since 2006 senior consultant for medical device industry (implants, active devices, etc.)

• Develop QM-Systems according EN9001 and 13485, 21CFR820 (FDA), MDD and MDR
• Successful certification and recertification with more than 20 companies
• Establish and implement validation concepts in various MedTech-companies
• FDA readiness, compliance and guidance through FDA investigations
• Establish and maintain technical documentations for CE-mark
• Internal and supplier auditing according ISO 9001, 13485 and FDA requirements
• Establishing custom made implant procedure; from X-ray/CT to implant
• Lead in more than 10 FDA inspections
• Coaching more than 15 start-up companies in quality management and product certification
• Giving public lectures about various topics of the medical device industry
• Technical due diligence analysis in aerger and acqusition situations for both sides

• Medical Devices (orthopedic, spine and ophthalmic implants and instruments, active devices with and without software, therapeutic devices, dental systems)
• Materials (metals and polymers)
• Manufacturing and cleaning procedures
• Quality management and validation of equipment, production and inspection processes
• Cleanliness validation and biocompatibility testing
• Quality system, process and supplier auditing
• FDA Investigation: pre and post audit activities as CAPA plans and communication to FDA
• Spontaneous projects to achieve and/or maintain compliance
• Lead and coach change management processes
• Human resources management and Swiss labour law

• > 20 years in medical device industry
• > 18 years of experience as project leader
• > 10 years in line management, thereof 7 years as Head of Development
• Operating of clean rooms according to 14644-1
• Extensive field experience in operating theatres
• 1.5 years of experience as a teacher at a private school

• Development of medical products of classes I, Ir, Is, IIa, IIb, III, mainly hip joint implants and surgical instruments, including successful market launch and maintenance
• Fatigue tests of class III hip implants according to ISO 7206-2/4/6/8
• Tribology of artificial hip joints
• Development of products for surgical navigation
• Project manager for electro-mechanical patch pumps for liquid drug delivery
• Master’s thesis EMBA: ‚Bedarfsabklärung für eine Einzelsteril-Nachweismethode‘

• Life cycle management of medical devices
• Development and maintainance of technical files
• CE conformity assessment
• Design verification and validation of medical products including application in the field
• Definition of materials for medical devices (metals and plastics)
• Reprocessing of medical devices (class Ir) according to ISO 17664
• Cleaning, packaging and sterilisation of medical devices including transport validation (ISO 11607-1, -2, ISTA, ISO 11137-1, -2)
• Behaviour in clean rooms and sterile areas (operating theatre)
• Maintenance and optimization of Quality Management Systems according to ISO 9001 und ISO 13485, with focus on processes development/design, cleaning, packaging, sterilisation
• Supplier audits according ISO 13485
• Risk management according ISO 14971 and TR 24971
• Labelling of medical products according ISO 15223-1, -2
• Application of CAD software and FEM (finite element methods)

• 27 years in the international medical device industry in various roles
• 20 years management responsibility in different positions
• 20 years quality management responsibility medical devices (ISO, GMP)
• 10 years product management and marketing experience
• 10 years in business coaching/ organizational development
• Lecturer at SAQ Qualicon
• More than 170 internal and external audits in various roles (ISO 13485 and FDA)

• Develop QM-Systems according to ISO 13485, MDD/MDR, 21CFR820 (FDA)
• Establish and implement international complaint management and after sales systems
• Internal and supplier audits according ISO 9001, 13485 and FDA requirements
• FDA readiness, compliance and guidance through FDA investigations
• Leadership coaching in various companies
• Lecturing on various topics (ISO 13485, ISO 9001, internal audit, supplier audit)
• Member of the examiner board for quality management and regulatory affairs training courses

• Medical Devices (diabetes care, pain therapy, treatment of late stage Parkinson’s disease, active devices with and without software, therapeutic devices)
• Diverse manufacturing procedures
• Lean Management
• Quality management (focus on complaint management, post market surveillance, vigilance, CAPA, audit)
• Audit activities (QM system, processes and suppliers)
• FDA Investigation: Responsible for pre and post audit activities including CAPA plans, warning letters and communication to FDA
• Projects to achieve and/or maintain compliance
• Lead and coach change management processes

• 5 years clinical evaluation according to MEDDEV 2.7/1 Rev. 4 and Regulation (EU) 2017/745 (MDR)
• 3 years technical documentation according to MDR
• 10 years clinical research in orthopaedics and traumatology
• 3 years team leading position
• 1 year biomechanical lab (biomechanical testing and motion analysis)

• Clinical evaluation according to MEDDEV 2.7/1 Rev. 4 and MDR for all risk classes, among others for bone plates, screws, nails, anchors, spinal implants, resorbable implants, surgical instruments, ophthalmologic devices, medical gases and their accessories, and high frequency surgery devices
• Compilation of technical documentations for medical devices according Annex II MDR
• Preparation of 510(k) file
• Clinical investigation plans and reports according to ISO 14155
• Post-market clinical follow-up planning
• Post-market surveillance planning
• Project lead of clinical data collection for FDA Premarket Approval application
• Numerous scientific projects in total joint replacement (ankle, hip), reconstructive surgery, and peri-prosthetic joint infection, including statistical planning, execution, analysis and publication
• Conception and maintenance of registry for long-term total joint arthroplasty surveillance
• Biomechanical testing of prophylactic bone augmentation methods

• Clinical evaluation according to MEDDEV 2.7/1 Rev. 4 and MDR
• Systematic scientific literature search and evaluation
• Technical documentation
• 510(k) submission
• Writing and reviewing of scientific and regulatory documents, papers and reports
• Post-market clinical follow-up studies
• Post-market surveillance
• Clinical research project management
• Legal and ethical aspects of clinical research
• Statistical analysis
• Publication process