Opra Start is product one of seven. Each one ships standalone in six weeks. Together they form a connected intelligence layer for medical device operations — the path to OPRA FLOW.
Seven focused tools, each priced to stand alone, each built to chain into the next. Follow the line.
Product definition
Guide a team from ideation to a fully traceable product definition. User groups, needs, URS, Intended Use, PRS — all linked, all audit-ready.
Risk management
Extends OPRA START into ISO 14971 risk management. Every risk control in your PRS links back to a hazard. Benefit-risk analysis built in.
Design controls
Project management built for medtech. Understands design-control phases and generates ISO 13485-compliant project plans with the correct document gates.
Parts & BOM
A structured parts library and BOM builder. Every part carries its regulatory attributes. Component changes propagate to affected documents and risk files.
Asset management
Full lifecycle for lab equipment, test instruments, and manufacturing assets. Calibration, maintenance, qualification — maintained automatically, linked to V&V.
Audit automation
Continuously monitors your quality system against ISO 13485, EU MDR, and FDA. Identifies gaps, recommends CAPAs, produces evidence packages on demand.
Supplier management
Supplier qualification and ongoing control. Approval workflows, technical questionnaires, audit scheduling, AVLs — connected. Supplier changes trigger impact assessments.
Every founder starts somewhere. Buy OPRA START today, add products as you grow, and let the constellation guide you toward OPRA FLOW.