Standards
| Standard | Standard URL |
|---|---|
| ISO 13485 - Medical Devices | ISO 13485:2016 |
| ISO 14971 - Risk Management | ISO 14971:2019 |
| EU Harmonised Standards (AIMD) | Harmonised to AIMD Directive 90/385/EEC |
| EU Harmonised Standards (IVD) | Harmonised to IVD Directive 98/79/EEC |
| EU Harmonised Standards (MD) | Harmonised to MD DIrective 93/42/EEC |
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