Trade Lead 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 Qualificat
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Posted from China - Guangdong on 3 December, 2012 Last Modified on 5 December, 2012
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