Qualcy eQMS provides simple interface for managing design control process for medical device applications. This includes,
Qualcy eQMS provides simple interface for managing design control process for
medical device applications. This includes,
Design and Development Planning for Project overview and objectives, roles and responsibilities, Design review schedule.
Documentation of Design Inputs with User needs and intended use, Regulatory requirements (FDA, EU MDR, etc.), Functional and performance requirements, Interface requirements (mechanical, electrical, software), Human factors and usability considerations, Risk control measures (linked to hazard risk assessment)
Design Outputs documentation for Product drawings and specifications, bill of materials (BOM), Manufacturing processes, Labeling and packaging specifications
Design Reviews for Review agendas and attendees, Meeting minutes, action items and resolutions, design review sign-offs
Design Verification include Verification protocols and test plans, Trace matrix (inputs linked to tests), Test reports with data and analysis, Summary of verification results
Design Validation documentation including Validation plan and rationale, Usability testing protocols, Clinical data (if applicable), Test reports and summary, Evidence devices were production-equivalent
Design Change management with option for Change request forms, Impact assessment, Revised documents (inputs, outputs, test results), Re-verification and/or re-validation evidence, Change approval signatures
Risk Management Files include Risk analysis (with FMEA and ISO 14971) for Hazard identification, Risk control measures, Residual risk acceptability
Traceability Matrix, Mapping of Design inputs to Design outputs, Inputs Verification and validation activities, Risks analysis to Controls and tests