ISO 13485:2016 specifies a quality management system requirement where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Maintaining compliance with ISO 13485:2016 requirements ensures the manufacturer’s efficiency in the following areas:
- Robust quality & process control: Ensures standardized workflows, validated production processes, and consistent product quality across all stages.
- Regulatory compliance & risk management: Aligns with global medical standards while proactively identifying and mitigating risks throughout the product lifecycle.
- Traceability & continuous improvement: Enables full product traceability, effective CAPA systems, and ongoing enhancement based on feedback and performance data.
As an ISO 13485-certified facility, Thygesen is proud to have the following scope covered under this certification:
- Manufacture and supply medical apparels: Medical fabric face masks; Medical headwear (Turbans, Hats, Caps, headband)
- Thermal Pack- Hot or Cold – Reusable (Revitalizing thermal mask, Miracle headache relief, Miracle arch relief, Miracle back relief, Miracle foot relief, Miracle eye relief, Miracle knee relief)
- Hygiene products (menstrual underwear) for hospitals, nursing homes and home care
We take quality very seriously and commit to providing services and products that meet international standards.
