TESTING & REGULATORY SUPPORT

Creation and maintenance of Design History Files (DHF) and Device Master Records (DMR)
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Coordination and review of solutions with notified bodies and testing labs
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Verification testing to essential requirements and medical safety standards
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Compliance to design control requirements
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FMEA
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Performance
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Formal verification
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Compliance to standards
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Transit
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Reliability
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Life

Regulatory support is offered through one of our partners.