Our Expertise Across Domain New Product Development Design Feasibility Customer Needs -> Product RequirementsISO 14971 Risk ManagementCloud Hosting ApplicationsIEC 62304 & TIR45, AGILE Software DevelopmentSoftware Lifecycle ManagementIEC 62366 Human Factors & Usability EngineeringDesign Verification; Test Case Development & Protocol WritingDefect Management & Software Problem ResolutionDesign TransferSoftware & Product Release Compliance & Regulatory Quality Systems SOP Development QMS Process Creation Change ControlAudit Preparedness & Mock InspectionQuality Support - Product Development TeamsGMP Training Compliance Gap Analysis510k Regulatory SubmissionIVDR Performance Evaluation Preparation Testing & Production Validation Test Plan & Protocol Creation Computerized System Validation (CSV) Software Tool Qualification & Governing SOP developmentProcess Validation Test Method ValidationKaizen Process Map Evaluation Expertise Across Industry Contact us.Let us help you turn ideas into healthcare solutions. Contact Contact Form Name * First Name Last Name Email * Phone * (###) ### #### Subject * Message * Thank you!A member of our team will be in touch with you within 24 hrs.