Left Coast Engineering has supported complete product certifications for more than a dozen product design projects which required certification. The company has specific expertise in FCC, CE and UL certifications from start to finish.
In particular, LCE is a leader in Medical Device design, having supported products through the 510(k) process using the company’s established FDA-compliant design control process and documentation templates.
This includes:
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Incorporating certification requirements into LCE’s designs as well as reviewing existing designs for any hurdles that could cause trouble during the certification testing.
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Preparing certification units and working with the testing lab on test plans and required documentation.
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Supporting the certification testing as it is performed by the testing lab.
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Determining cost-efficient mitigations for any discovered testing non-compliance.
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Incorporating mitigations into final manufacturing package.
