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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
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