ISO13485 certificate consultation services

• 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