Medical Device > Quality Systems
- Quality Systems audits/assessments, pre-certification audits,
- Quality Systems implementations, process improvement, SOP development, work instruction and procedures development
- ISO certification assistance for ISO 13485:2003
- ISO 9001 and ISO 13485:2003 training programs
- Batch Records documentation
- Complaints, CAPA, Adverse Event, and MDR processes and systems
- Device master record/technical files remediation
ISO 13485:2003 Audit and Transition Services
Medical device manufacturers can achieve substantial benefits in quality by transitioning to this new standard. ISO 13485:2003 provides a process approach to quality management that focuses on:
- The need to consider processes in terms of added value
- Obtaining process performance results
- Improvement of processes based on objective measurement
- Meeting customer requirements
- Meeting regulatory requirements
We offer a full scope of services to help you implement this standard.
- Our Approach / Our People
- Project-based Services
- Experience / Program & Project Management
