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our consultants
beat u steffen (managing director confinis ag, partner)
education:
- executive MBA in leadership and strategic management
- post diploma in business administration - focus on project management
and services
- master of science in electrical engineering
- electro-technician apprenticeship
professional experience:
- lead auditor for a notified body regarding ISO 13485, directive 93/42/EEC and CMDR under CMDCAS
- lecturer at berne university of applied sciences (design control, software life-cycle (IEC 62304) and process / computer system validation (GAMP 5))
- chairman of the board of a pension fund
- developed risk management process for medical devices according to ISO
14971 (public medical device company)
- built-up and spear-headed project management department in a public medical
device company
- senior project manager (new product development) in a public medical
device company
- hard- and software development for medical devices
- hard- and software development for public transportation systems
seats:
- swiss delegate, ISO committees TC 76 (transfusion, infusion and injection equipment for medical and pharmaceutical use), TC 84 (devices for administration of medicinal products and intravascular catheters) and TC 210 (Quality management and corresponding general aspects for medical devices)
languages:
- german, english, french, italian
samuel lainez (president confinis usa, partner)
education:
- master of science in industrial engineering with concentration of computer
systems application
- bachelor of science in electrical engineering
professional experience:
- consultant services and project management for medical device, biotech
and pharmaceutical companies
- quality system development
- software development life cycle
- auditing to establish compliance with FDA regulations and industry standards
for software development and computer system validation (CSV)
- auditing to establish compliance with FDA regulations for electronic
records and electronic signatures (21 CFR part 11)
languages:
- english, spanish, portuguese
joerg dogwiler (senior consultant, partner)
education:
- master of science in electrical engineering (eth zurich)
- traineeship at the german aerospace center in oberpfaffenhofen
- high school
professional experience:
- interdisciplinary project management in product development for medical and automotive industry
- worldwide product market approval procedures in cooperation with notified bodies
- development and qualification of test systems based on GMP guidelines
- development and verification of hardware and related firmware for different products in automotive and medical industry based on applicable quality management systems ISO9001, QS9000, VDA6.1, TS16949 and ISO13485
- group leader of system engineering for power plant technologies
seats:
- swiss delegate, ISO committee TC 210 (Quality management and corresponding general aspects for medical devices)
languages:
- german, english, french, italian
mathias t eng (senior consultant, partner)
education:
- master of advanced studies in computer science
- bachelor of science in civil and structural engineering
professional experience:
- quality management system (ISO 9001 / ISO 13485 / 21 CFR Part 820)
- software lifecycle processes (IEC 62304)
- risk management (ISO 14971, ICH Q9, ISO/DTR 80002)
- process validation / csv (GAMP4 / GAMP5, 21 CFR Part 11)
- usability engineering (IEC 62366)
- interdisciplinary project management (cGxP environment)
- lifecycle management
- premarket submissions for medical devices including software
- design history file remediation activities
- verification and validation activities (design and process)
- product development processes for medical devices (MDD, IVD and AIMD)
- electronics lifecycle processes
- mechanics lifecycle processes
- assessments and training
- auditing and gap analyses
- development of embedded software (e.g. real-time application framework for MSP430 derivatives which is successfully used in several products)
languages:
urs widmer (senior consultant, partner)
education:
- post diploma in business administration - focus on project management and services
- master of science in mechanical engineering
- mechanical designer
professional experience:
- interdisciplinary project management in product development; built up, introduced and trained a product development process in a medical device company
- department manager technical product support (sterile and non sterile products) in a public medical device company
- department manager and project leader research and development of sterile and non sterile products in a public medical device company
- project leader mechanical design (new product development) in a public medical device company
- development engineer for sterile and non sterile medical devices in a public medical device company
seats:
- swiss delegate, ISO committees TC 76 (transfusion, infusion and injection equipment for medical and pharmaceutical use) and TC 84 (devices for administration of medicinal products and intravascular catheters)
languages:
caroline brugger (senior consultant)
education:
- diploma in biomedical engineering (university of applied sciences)
professional experience:
- quality management, release of finished goods, quality systems, product care, CAPA
- design control
- product risk management acc. to ISO 14971, FMEA, FTA
- project management for medical devices
- industrialisation of high volume projects
- qualification and validation of manufacturing equipment and processes
- definition of production processes and material flow, commissioning
- optimisation of design control processes
languages:
english
deutsch