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Quality/regulatory support
Organization name
Qualix
Offering type
STRATEGY AND DEVELOPMENT
Target customers / applications
[INDUSTRY] SMEs
[INDUSTRY] Midcaps
[INDUSTRY] Large Enterprise
[RESEARCH] Research and technology organisations
Field of application
Health
STRATEGY DEVELOPMENT SERVICES
[Product Trajectory] - IPR issues
[Product Trajectory] - Product development & Roadmap
COMMUNITY BUILDING SERVICES
SKILLS AND TALENTS SERVICES
BUSINESS SUPPORT SERVICES
Offering Description
Support organizations active in the (in vitro diagnostic) medical device field with the following services: - Set up, implement and/or modify Quality Management System (ISO13485) - Regulatory file writing, coordination and submission - Outsourced Quality /Regulatory affairs management (QA management ad interim) - Audit assistance (internal audits, notified bodies audits, competent authority inspections - Training
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