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.
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.
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