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ISO13485 certificate consultation services

Inquiry
  Post Date: Mar 25,2013
  Expiry Date: Mar 25,2014
  Detailed Description: 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



  Company: osmunda medical device consulting company     [ China ]        
  Contact: osmunda
  Tel: 020-62321333
  Fax: 020-37612253
  Email: sfda@osmundacn.com
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