Independent consulting and service company in the healthcare sector focusing on maintenance and reprocessing of medical devices
Medise GmbH
Feldbrunnen (SO), SwitzerlandNew on Amplifa
About Medise
Medise GmbH was founded in 2023 by Martin Iseli in Feldbrunnen (Canton of Solothurn) as a neutral and independent consulting and service company in the healthcare sector. The focus is on medical technology, in particular the maintenance of medical devices covering servicing, repair, reprocessing, logistics, hygiene processes, risk management, quality management and training. The company supports hospitals, practices and clinics in establishing and maintaining QM systems according to EN ISO 9001 and EN ISO 13485, with regulatory matters vis-à-vis Swissmedic and cantonal therapeutic product authorities, as well as before and after authority inspections. Further services include project management for new-build and renovation projects in the fields of medical technology, logistics and reprocessing, including commissioning and validation (IQ/OQ/PQ), training and continuing education of specialist staff, and sales support with market analyses for the Swiss market. As a small company, Medise works flexibly and with personal customer contact, drawing on a network of cooperation partners for larger projects.
- Site
- Feldbrunnen/SO
- Processes
- Maintenance of medical devices (servicing, repair), Reprocessing of medical devices (incl. validation IQ/OQ/PQ, hygiene processes), Quality management (EN ISO 9001, EN ISO 13485, risk management, internal audits), New-build and renovation projects medical technology/logistics/reprocessing (project management,, Training and continuing education, Regulatory consulting (authorities, Swissmedic, inspections), Sales and maintenance of medical devices (market launch, service organization, spare parts, Maintenance of medical devices
- Materials
- Maintenance of medical devices, Reprocessing of medical devices, Quality management, Regulatory consulting, New-build and renovation projects, Training and continuing education, Sales and maintenance of medical devices
- Certificates
- EN ISO 13485 (certification support for customers)
- Founded
- 2023
- Industries
- Healthcare, Medical technology, Hospitals, Practices and clinics
- 01
Analysis and consulting (regulatory affairs, QM, reprocessing processes)
- 02
Project management and implementation (new-build/renovation, processes)
- 03
Commissioning and validation (IQ/OQ/PQ)
- 04
Maintenance, reprocessing, QM operation
- 05
Training and continuing education
Services and Methods
Maintenance of medical devices
Servicing, repair and equipment fleet management for medical technology.
Reprocessing of medical devices
Analysis, optimization and validation (IQ/OQ/PQ) of reprocessing and hygiene processes.
Quality management
Establishment, implementation and certification support for QM systems according to EN ISO 9001 and EN ISO 13485, including risk management and internal audits.
Regulatory consulting
Support with regulatory matters and authority contacts (Swissmedic, cantonal therapeutic product authorities) before and after inspections.
New-build and renovation projects
Project management, operating concepts, tenders, owner representation as well as commissioning and validation of new processes and systems.
Training and continuing education
Workshops and training for technical and medical specialist staff as well as sales personnel.
Sales and maintenance of medical devices
Market analyses, market launch, service organization and spare parts inventory for the Swiss market.
Location
Feldbrunnen
CHHead office/Office
Service Areas
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Maintenance of medical devices (servicing, repair)Assembly | – | – | – | – | – |
| Reprocessing of medical devices (incl. validation IQ/OQ/PQ, hygiene processes)Surface | – | – | – | – | – |
| Quality management (EN ISO 9001, EN ISO 13485, risk management, internal audits)Testing | – | – | – | – | – |
| New-build and renovation projects medical technology/logistics/reprocessing (project management,Engineering | – | – | – | – | – |
| Training and continuing educationEngineering | – | – | – | – | – |
| Regulatory consulting (authorities, Swissmedic, inspections)Engineering | – | – | – | – | – |
| Sales and maintenance of medical devices (market launch, service organization, spare partsAssembly | – | – | – | – | – |
Additional services
Reference customers
Quality
Medise supports customers in establishing, implementing and certifying QM systems according to EN ISO 9001 and EN ISO 13485, conducts internal audits and risk management, and trains staff in normative and legal requirements.
| Evidence | Feldbrunnen |
|---|---|
| EN ISO 13485 (certification support for customers) |
History
- 2023
Founding of Medise GmbH by Martin Iseli as a neutral consulting and service company in the healthcare sector with a focus on medical technology.