Regulatory and quality management consulting for medical device development and MDR compliance. Supports companies through risk assessment, market requirements analysis, CE marking processes, and digital documentation systems to ensure safety and regulatory adherence.
Manufactured by
3R LifeScience GmbH
Berlin, Germany
Product development and market approval of medical devices according to ISO 13485 and MDR 2017/745: Innovation management and development strategies Requirements management and integrated risk management Supplier management and outsourced processes External product development and project management Quality management processes and Technical Documentation Interim Management in regulatory affairs and compliance.
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ROOSON Consulting Service Co. Ltd · China
Regulatory consulting services for medical device market access, including clinical trial design, registration support, quality management system development, and international certification guidance for manufacturers seeking approval in China and global markets.
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Medical consulting services specializing in research, development, production, and commercialization strategy for medical devices and diagnostic equipment. Provides comprehensive enterprise solutions integrating product development, scientific research, and market implementation for healthcare organizations.
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Professional consulting services for medical device development, material selection, and manufacturing process optimization. Leverages 25+ years of expertise in quality-focused medical device production.
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