Quality management and regulatory consulting service supporting medical device manufacturers in MDR compliance, CE marking, and regulatory documentation. Provides expert guidance on risk management, development processes, and quality system optimization to ensure safety and performance requirements ...
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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WQS Management Consultants Inc. · United States
Regulatory consulting service guiding medical device manufacturers through EU MDR compliance, CE certification, ISO 13485 quality management systems, and technical documentation requirements for market authorization.
D.med Technologies AG · Switzerland
Regulatory Affairs & Quality Management consulting service for medical device development. Provides end-to-end support from concept through market compliance, including design review, regulatory strategy, and standards alignment (ISO 13485, ISO 9001). Enables manufacturers to navigate regulatory pathways for Class II and Class III devices efficiently.
Guangzhou MedClear Medical Device Service Co., Ltd. · China
Provides quality and regulatory consultation services for medical devices, including regulatory compliance, quality management systems, and full lifecycle product support. The service includes sterilization validation, sterilization processing, testing, and regulatory consulting to ensure complete compliance throughout the product lifecycle.
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