4E continues its high commitment to quality.
Here at 4E we are delighted to announce our continued accreditation to ISO 13485:2016 International Quality Management Standard, with no non-conformances.
ISO 13485:2016 is the International Standard for Design and Manufacture of Medical Devices and requires more attention to regulatory requirements than ISO 9001. We at 4E are proud that our continued hard work and commitment to quality has paid off.
The ISO 13485 focuses 4Es attention on…..
- Regulatory Requirements
- Client Requirements
- Risk Management
- Legal Compliance
- Traceability and Recall
- Process Improvement
- Operational Efficiency
4E would like to thank Emma Meehan, Quality Manager, and the whole team for all their hard work throughout the assessment and their continual attention to detail and quality across the company.