ISO 13485 Certification Consulting

-  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