QM and process consulting for medical device manufacturers
Quality Management System
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Establish ISO 13485:2016 compliant processes
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Process framework for compliance with regulatory requirements
(e.g., QMSR acc. with 21 CFR Part 820, EU-MDR)
NC and CAPA
- Create or optimize NC and CAPA processes
- Hands-on support for complex or overdue CAPAs
- Remediation of already closed CAPAs
- CAPA training for beginners to experts
Business Process Management
- Process map development
- Process modelling (EPC; BPMN 2.0)
- Establishing social BPM (BPM 2.0)
Project management
- Project management handbook
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- Creation and consulting
- Project manager for
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- Organization projects
- ERP projects
- Change mangement projects
My mission statement
Water.
In continuous movement and alteration.
Adaptable in form, stable inside.
The formative power of many drops.
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Organization.
Like water, open for changes, but stable inside and powerful in creation.
A lively organization as the foundation for corporate success.
This is my credo.
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Organizational and Quality Management Process Consulting for Medical Device companies
with strategic focus, accurate implementation and comprehensive progress.
Martin R. Goetschi Consulting for sustainable success to your business.
A warm welcome on my web site of Martin R. Goetschi Consulting!
Sustainable consultancy for all quality management aspects of the medical device industry.
My consulting has a strategic focus, will be executed precisely and delivers you a significant progress for your business, always in full compliance wiht regulatory requirements. Consultancy with the potential for ongoing success to your business
Therefore, stay tuned and witness how the consultation expertise is going to continuously improve and unfold.
Yours sincerely,
Martin R. Goetschi