Consulting and interim management for quality, regulatory affairs and validation in the life science industry.
DeltaSCI Solutions GmbH
Winterthur (CH) · HeadquartersNew on Amplifa
About DeltaSci Solutions
DeltaSci Solutions GmbH is a consulting company founded in 2020 in Winterthur, focused on the life science industry, in particular medical technology. The company supports clients with quality and regulatory affairs matters as well as technical and scientific tasks. Its services include equipment qualification, validation of methods and processes, creation, interpretation and review of technical documents (procedures, reports, statistical evaluations, risk management) as well as collaboration as an interface to external laboratories. Further offerings include interim management (interim team, department and project management, HR management, continuous improvement projects) as well as regulatory surveillance with defect analysis, impact analysis of deficiencies discovered by authorities and evaluation of market feedback. Projects are structured into a development and mentoring phase, an execution phase and a monitoring phase. Owner and contact person is Nils Weiler, graduate chemist (FH), with more than ten years of experience in medical technology, including Medical Device Regulation, chemical characterization, audits and submissions to notified bodies and authorities; he is also a Six Sigma and Lean specialist. Work is performed in German and English.
- Site
- Winterthur
- Processes
- Consulting and support (equipment qualification, validation of methods and processes), Interim Management (project management, HR management, improvement projects), Regulatory surveillance (defect analysis, standards and standard portfolio), Consulting and support for the life science industry, Equipment qualification, Validation of methods and processes, Creation, interpretation and review of technical documents (procedures, reports,, Interface to external laboratories
- Materials
- Equipment Qualification, Technical Documentation, External Laboratories, Interim Management, Regulatory Surveillance
- Founded
- 2020
- Employees
- 1
- Industries
- Life Science, Medical Technology, Manufacturing of Medical Devices, Consulting
- 01
Initial assessment (as-is/to-be state)
- 02
Action plan with milestones
- 03
Execution phase (implementation)
- 04
Progress reporting
- 05
Monitoring phase with performance indicators
Services and Methods
Equipment Qualification
Equipment qualification as well as validation of methods and processes for the life science industry.
Technical Documentation
Creation, interpretation and review of technical documents incl. statistical evaluation and risk management.
External Laboratories
Interface to external laboratories for analyses and testing.
Interim Management
Interim team, department and project management as well as HR management and improvement projects.
Regulatory Surveillance
Defect analysis with relevant standards, impact analysis and evaluation of market feedback.
Locations
Winterthur
CHHeadquarters with consulting offering
Service Areas
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Consulting and support (equipment qualification, validation of methods and processes)Engineering | – | – | – | – | – |
| Interim Management (project management, HR management, improvement projects)Engineering | – | – | – | – | – |
| Regulatory surveillance (defect analysis, standards and standard portfolio)Testing | – | – | – | – | – |
Additional services
History
- 2020
Foundation of DeltaSci Solutions GmbH in Winterthur