Service Center

SERVICE CENTER

Service Center

CDMO

Product design and development
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Product design and development Service items:

Product market research and project demonstration;

Formulate product performance indicators, clarify adoption standards, conduct similar product research, safety analysis and other technical services......

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Registration type inspection
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Registration Type Inspection Service Items:

Guide the drafting of technical requirements and formulation of testing plans;

Inspection agency screening, sample inspection, and progress coordination;

EMC investigation and rectification......

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Product registration (filing)
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Product Registration (Record) Service Items:

Registration and change of Class I medical devices;

Registration, change and renewal of Class II and III medical devices;

International registration services (United States, European Union, Canada, etc.)......

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Product trial production
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Product Trial Production Service Items:

Trial production plan/report design and guidance;

Small sample development;

Raw material supplier screening and evaluation, process optimization......

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Clinical trials
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Clinical Trials Services:

Writing of clinical evaluation materials;

Consultation and guidance on clinical literature research/paper translation, etc.;

Clinical trial program design......

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Product production
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Production Services:

Confirmation of quality management system compliance;

Product production risk management;

Sample production......

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Animal Experiment Services
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Animal Experimentation Services Service Items:

Overall outsourcing of animal experiments;

Animal experiment program design;

Animal experiment base screening......

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Establishment of Quality Management System
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Quality Management System Establishment Service Items:

Design/establishment/training of quality management system;

Audit services for production workshops, production equipment and other hardware;

Establishment and training of quality management system personnel team......

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