06.12.2024 aktualisiert
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Expert advisor medical device
Jegenstorf, Schweiz
Schweiz
Dipl Ing FHSkills
ISO 14971iso 13485ISO/TR 20416Digitale TransformationCAD EntwicklungSystem EngineeringRisk management ISO 14971Quality & Risk ManagementIEC 62366IEC 60601 SerieCreo ParametricsMedical Device
Holistic process development for medical device development considering:
- MDR 2017/745
- 21CFR Part 820
- 21CFR Part 11
- Risk management ISO 14971:2019 & ISO/TR 24971:2020
- Post-market surveillance ISO/TR 20416
- Quality Management ISO 13485:2016
- Usability engineering IEC 62366-1:2015 & IEC/TR 62366-2:2016
- Clinical investigation ISO 14155:2020
Leading workshops to improve the content workflow for medical device development, get ready for digital transformation
Technical documentation reviews for medical device class I, IIa, IIb, and III
Project manager for active medical device
Build up a documentation principle for content driven documentation (CMS for doc control)
- MDR 2017/745
- 21CFR Part 820
- 21CFR Part 11
- Risk management ISO 14971:2019 & ISO/TR 24971:2020
- Post-market surveillance ISO/TR 20416
- Quality Management ISO 13485:2016
- Usability engineering IEC 62366-1:2015 & IEC/TR 62366-2:2016
- Clinical investigation ISO 14155:2020
Leading workshops to improve the content workflow for medical device development, get ready for digital transformation
Technical documentation reviews for medical device class I, IIa, IIb, and III
Project manager for active medical device
Build up a documentation principle for content driven documentation (CMS for doc control)
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse
Projekthistorie
- Support in the organisation of technical documentation
- Writing technical documentation, especially test methods and verificaiton reports
- Designing of trauma implants (CAD Creo parametrics, free form surfaces)
- Writing technical documentation, especially test methods and verificaiton reports
- Designing of trauma implants (CAD Creo parametrics, free form surfaces)
- Process landscape analysis
- Assessment of the level of digitalization in product life cycle
- Workshop for process improvements
- Assessment of the level of digitalization in product life cycle
- Workshop for process improvements
Gap analysis for material standards:
Implant material ASTM vs ISO
Instrument material ASTM vs ISO
Gap assessment internal material specification
Implant material ASTM vs ISO
Instrument material ASTM vs ISO
Gap assessment internal material specification