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electrosurgical generators design & manufacture & regulatory compliance for medical systems medical equipment manufacturing product validation and verification medical equipment and supplies manufacturing manufacturing product design and manufacturing quality assurance medical equipment biotechnology product development project management consulting fda 510(k) submissions european notified body audits services semiconductor industry expertise medical device patents product development manufacturing support supply chain management rf energy devices fda and international standards quality system audits regulatory guidance and support design control process medical technology biotech and semiconductor streamlining prototyping and manufacturing medical device manufacturing regulatory approvals prototype to production