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Regulatory Support
 Our engineering staff will also support your overall system design and certification efforts with the design and documentation necessary for regulatory submissions.
| European Union directives |
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Medical Device Directive
Low Voltage Directive
EMC Directive |
| Regulatory submissions |
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FDA 510K
UL2601
EN60601-1
UL, CE, TUV, CSA |
| System safety analysis |
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Risk analysis
FMECA, FTA
Human factors |
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