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Iso13485 Certificate Consultation Services - China

price: contact company for price

Osmunda has successfully assisted nearly 1, 200 domestic and foreign

enterprises in achieving various medical device registrations and

certifications. We are your most trustful partner and 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


- 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 Consultation Services

Please see our contact information below

Company Contact:

  • Phone: 862062321333

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

  • Email: Email

Published date: December 3, 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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