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  • Iso13485 Certificate - China

    price: contact company for price

    Osmunda has successfully assisted nearly 1, 200 domestic and foreign

    enterprises in achieving various medical devices registration and

    certification. We will be your trustful partner and your most

    professional guide. We can:

    - analysis of company needs, applicable regulatory and statutory requirements and, where applicable, customer specifications and expectations

    - pre-assessment and gap analysis of existing Quality Management System

    - design and integration of ISO 13485-compliant Quality Management Systems

    - Quality Management System development and implementation action plan

    - preparation of Quality Manual, policies, procedures/protocols in line with ISO 13485

    - GMP /cGMP- (current) Good Manufacturing Practices requirements

    - Document Control, including applicable forms, templates, publications, etc.

    - Control of Records, Data Management, R&D, manufacturing, shipping, traceability and QA

    - research and assistance in preparation of the specifications, procedures and standards

    - Design Qualification (DQ), Process Qualification (PQ) and Operational Qualification (OQ)

    - Risk Assessment and Failure Mode and Effect Analysis

    - selection and customization of suitable software

    - step-by-step guidance and on-going advice throughout the program

    - hands-on participation in Quality Management System implementation

    - Internal Audits and Management Review activities

    - preparation of the Quality Management System for the assessment

    - assistance during Quality Management System assessment by the Registrar

    - post-assessment follow-up support

    BENEFITS:

    - no hassles (and extra costs) associated with external training

    - compliance with ISO 9001/13485 and other regulatory and statutory requirements

    - trained and motivated personnel

    - better documentation, repetitive processes, improved performance

    Iso13485 Certificate

    Feel free to contact us with all your questions


    Company Contact:


    • Phone: 862062321333

    • Address: 7th Floor, Jingui Business Building, No.982 Congyu, Guangzhou, China

    • Email: Email


    Published date: September 7, 2012 -

    • Business Description: Osmunda Medical Device Consulting Organization

      (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the

      largest and most professional consulting company in the field of medical

      device in China. All Osmunda Consultant team members are from sizeable

      medical devices enterprises, well known notified bodies and testing

      organizations. We are well versed in global various medical device

      quality system certification and product registration, such as SFDA

      registration, QSR 820 system, FDA registration, ISO 13485 system, CE

      certification etc. Our service includes clean room design, clinical

      trail, third party audit, training of regulations and standards, etc.

      Our headquarters is in Guangzhou, and we have five branch offices (Beijing, Shanghai, Suzhou, Shenzhen, Jinan) which could provide high speed local services and communication. By far, Osmunda has successfully assisted nearly 1,200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most professional guide.

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