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DirectoryBusiness & Technical ServicesManagement ConsultingZurichSpruce Group GmbH
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Spruce Group GmbH

Summary

About the company

Spruce Group GmbH is a consultancy serving regulated manufacturing sectors, offering services such as validation, quality management, project management and supplier oversight. It supports medical device, pharmaceutical, semiconductor and molecular diagnostics manufacturers with regulatory compliance, process and equipment validation, commissioning/qualification and cybersecurity/compliance services.

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Products & services

Industry:Management ConsultingTechnical Consulting & Engineering
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Validation
Validation of equipment, software and processes for regulated manufacturing environments; process, device, software, test method and biocompatibility validation.
Quality Management & Compliance
Support for QMS documentation, deviations and complaint handling, regulatory gap analysis as well as planning of timelines and costs for ISO 13485, FDA 21 CFR Part 820 and EU MDR/IVDR.
Project Management
Project management for product development and compliance projects with gap analysis, timelines and costing and budgeting for on-time and cost-efficient implementation.
MDR Compliance Consulting
Consulting on the Medical Device Regulation with MDR implementation, readiness, validation, training and hands-on support for medical device manufacturers.
Supplier Management
Supplier sourcing, pricing optimisation, supplier audits and contract manufacturing oversight for regulated production and procurement processes.
Sterilization Support
Validation of sterilization methods, bioburden and endotoxin testing, and documentation for regulatory approval.
Technology Transfer
Transfer of products and processes from research and development into production, including scale-up, line transfers and regulatory compliance alignment.
Commissioning, Qualification & Validation (CQV)
Qualification of plants and facilities with cleanroom validation, HVAC and utilities qualification, and equipment and process validation.
Calibration & Instrumentation
Development of calibration programs, instrument qualification and metrology compliance for laboratory and production environments.
Cybersecurity & Compliance (NIS2 Directive)
Risk management and cyber resilience, data integrity and security as well as incident-response planning for regulated and critical sectors.
Start-Up Support
Guidance for start-ups in regulated industries with a start-up pack, coaching as well as timeline and progress analysis for quality, regulation and operational setup.
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Location

Hier entsteht die Karte
Technoparkstrasse 1
8005 Zurich

At a glance

Legal form
Limited Liability Company
UID
CHE-298.488.979
Founded
2024 · 2 years
Last commercial register change
March 7, 2025
Employees
1 to 10

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