Change control, end to end
Every change request flows from review to approval to training to a controlled release — reviewers, approvers and trainees each sign with their own e-signature.
✦ AI-powered operational excellence · by AYB Solutions
Compliance that moves
at the speed of innovation.
OPRA FLOW is one platform for medical-device operations — an audit-ready quality system and a living requirements-traceability engine, sharing one login, one audit trail, one source of truth.
OPRA Flow · Quality OSLIVEDocuments · Change control · CAPA · Training · Part 11 e-signatures
OPRA Start · TraceabilityLIVEUser needs → URS → PRS → IU/IFU, always in sync
CR-019 · RELEASE LINEEVERY STAMP IS AN E-SIGNATURE
AUDIT READY · 100% TRACEABLEreviews → approval → training → controlled release
BUILT FOR
ISO 13485IEC 62366US FDA 21 CFREU MDRUKCA
Compliance should not slow down innovation.
Lessen the number of tools.QMS and requirements in one stack — consolidate your tech, retire the glue spreadsheets.
Centralise your data.Every record, signature and version in a single audit trail — one source of truth.
Streamline all workflows.Change control, CAPA and training that route themselves to the right people.
Reduce risk & save time.“Just enough” documentation to move fast without sacrificing audit readiness.
THE QUALITY ENGINE · OPRA FLOWYour QMS,
Your QMS,
alive on one screen.
Streamlined workflows, real-time analytics, seamless collaboration, digital signatures under 21 CFR Part 11 — these miniatures loop through the real product widgets, with the same stamps, seats and seals your auditors will see.
CAPA that closes the loop
Initiation to investigation to effectiveness verification, with dual-manager sign-offs and real-time analytics on where the quality system is straining.
Audit-ready by construction
Every case reads like the file an auditor wants: sections, stamps, actions and verdicts — including the failure path, visibly.
THE REQUIREMENTS ENGINE · OPRA STARTWhen one user need changes,
When one user need changes,
every downstream document knows.
The interactive traceability map — user groups to needs to URS, PRS and the IU/IFU — ships as the platform's second engine. Edit a need and watch the downstream documents flag, with reasons on the audit trail.
PROD-001Traceability
Pulse AI Wound Monitor
NEEDS6
UN-001
Apply monitoring patch without clinical training
Home Patient
UN-002
Receive alert when wound deteriorates
Home Patient
UN-004
Capture wound image for AI analysis
Home Patient
UN-003
Review wound healing progress during visit
Community Nurse
UN-005
Deploy device across trust network
Hospital IT Admin
UN-006
Validate AI algorithm against benchmarks
Biomedical Engineer
URS6
URS-001
Guided patch application
Functional
URS-002
Automated wound deterioration alerting
Functional
URS-004
Wound image capture with quality validation
Functional
URS-003
Clinical trend summary for nurse visits
Functional
URS-005
MDM deployment and SSO configuration
Non-functional
URS-006
Algorithm validation test harness
Functional
PRS7
PR-001
Patch placement feedback accuracy
Requirement · Clinical
PR-002
Alert latency for deterioration
Requirement · Clinical
PR-005
Risk control — alert failure fallback
Risk Control · Clinical
PR-004
Image quality rejection rate
Requirement · Clinical
PR-003
Trend summary load time
Requirement · Clinical
PR-006
MDM compatibility matrix
Requirement · Non-Clinical
PR-007
AI validation report export
Requirement · Non-Clinical
GROUPS4NEEDS6URS6PRS7IU2IFU3
LIVE · OPERATION → NEED → DOCS
product/pulse-ai-wound-monitor/operation + traceability
O
Product operation
01
Capture
Wound image + patch telemetry
02
Analyze
On-device AI deterioration risk
03
Alert
Threshold breach → alert state
04
Notify
Push to assigned care team
User groups: Home Patient, Community Nurse (+2)
N
User Need
“Receive alert when wound condition deteriorates”
Community nurse · home monitoring
Operational scope:Alert & Notify (steps 3–4). IU/IFU must describe this path accurately when the need changes.
Impacts:IUIFU
P
Products
- Pulse AI Wound Monitor
IUApproved
Intended Use
Last reviewed Apr 12, 2026
IFUApproved
IFU Document
Last reviewed Apr 14, 2026
WHAT WE OFFERA platform, and the people
A platform, and the people
who get you through audits.
SaaS eDMS platform
Controlled documents with versioning, review boards and training loops — audit-ready from day one.
CAPA management
Sections A–D with dual-manager sign-offs, action tracking and effectiveness verification.
Deployment & training
Guided onboarding, data migration and role-based training for your whole team.
Flexible support
From self-serve to a named quality partner — support that scales with your stage.
Full validation package
IQ/OQ/PQ documentation aligned to ISO 13485 and 21 CFR 820, maintained with each release.
Consultative partnership
Backed by 30+ years of sector experience — we help you capture 'just enough' to move fast.
OUR TARGET SECTORSAcademic researchersEarly-stage innovatorsSmall–mid medical device companiesDistributors & importers
THE CONSTELLATIONOne platform. Two engines live.
One platform. Two engines live.
Five more charted.
OPRA FLOW is live at the centre — the Quality OS and START ship today, and the constellation meets you wherever you are. Each product activates only when your work genuinely needs it.
OPRA FLOW · the destinationseven micro-products · ships in six weeks each
Contact us for timelines and interest in the entire collection.
Live now
OPRA START
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.
- Unified user-group and need capture
- Brain Dump — paste raw interview notes
- Shall / should language enforcement
- AI-assisted Intended Use drafting
- Medical vs wellness decision support
- Requirements Tree visualisation
Q1 2026
OPRA RISK
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.
- 8-category hazard classification
- ISO 14971 Annex D risk matrix
- Risk controls traced to PRS
- Cybersecurity and AI failure categories
- Residual risk sign-off workflow
- Benefit-risk analysis builder
Q2 2026
OPRA PLAN
Design controls
Project management built for medtech. Understands design-control phases and generates ISO 13485-compliant project plans with the correct document gates.
- Design-control phase management
- ISO 13485-aligned project templates
- CE Mark and 510(k) milestone tracking
- Document gate automation
- CAPA project management
- Team task assignment and audit trail
Q3 2026
OPRA BUILD
Parts & BOM
A structured parts library and BOM builder. Every part carries its regulatory attributes. Component changes propagate to affected documents and risk files.
- Structured parts library with regulatory attributes
- Version-controlled BOM management
- Linked to design-output requirements
- Biocompatibility status tracking
- UDI management built in
- Supplier link per component
Q4 2026
OPRA ASSETS
Asset management
Full lifecycle for lab equipment, test instruments, and manufacturing assets. Calibration, maintenance, qualification — maintained automatically, linked to V&V.
- Equipment calibration scheduling
- IQ OQ PQ documentation
- Maintenance record management
- Asset-to-validation activity linking
- 21 CFR Part 11 compliant records
- Audit-ready equipment history
Q1 2027
OPRA CHECK
Audit automation
Continuously monitors your quality system against ISO 13485, EU MDR, and FDA. Identifies gaps, recommends CAPAs, produces evidence packages on demand.
- Live audit-readiness score
- Automated gap identification
- Internal audit scheduling
- CAPA tracking and closure
- Evidence package generation
- Reads across all OPRA products
Q2 2027
OPRA CONTROL
Supplier management
Supplier qualification and ongoing control. Approval workflows, technical questionnaires, audit scheduling, AVLs — connected. Supplier changes trigger impact assessments.
- Supplier qualification workflows
- Approved-vendor-list management
- Supplier audit scheduling
- Critical vs non-critical classification
- Performance monitoring
- BOM and risk change propagation
ABOUT OPRA FLOWA UK-based team, backed by
A UK-based team, backed by
30+ years of sector experience.
We put AI and live data at the centre of compliance work, helping startups and innovative teams capture “just enough” documentation to move fast without sacrificing readiness for audits and scale-up.
Excellence
Quality work, delivered properly — the same bar we hold your documentation to.
Simplicity
Regulated software that reads in plain language, not technical frameworks.
Customer focus
Your success is our success. We build alongside the teams who use us.
AI ASSISTANTTOP SECURITYMOBILE INTERFACECENTRALIZED DATA
Prashant BajajFOUNDER & CEOThree decades across medical-device quality, operations and scale-up.
Dr. Prasanna Venkatesh RangaduraiCO-FOUNDER & CTOEngineering leader building AI-first regulated software.
GET IN TOUCH
Ready to get started?
Talk to the team.
contactus@opraflow.comFAQ
Questions, answered.
01What regulations does OPRA FLOW help with?
ISO 13485:2016 (§7.3.3, §7.3.9), IEC 62366-1 (§5.1 Use Specification, §5.2 User Needs), 21 CFR 820.30 Design Controls, EU MDR Annex I, and 21 CFR Part 11 for the audit trail and e-signatures. We map every artifact to its specific clauses.
02What is change propagation?
When you edit a User Need or update a user-group profile, OPRA FLOW flags linked URS entries and cascades downstream to PRS, Intended Use (IU), and IFU documents where applicable. Each flag carries a reason and is logged in the audit trail. You review, approve, and move on — no spreadsheet hunting.
03Can I use OPRA FLOW for SaMD (Software as a Medical Device)?
Yes. SaMD teams are our core users. The model — user groups, needs, products, IU, IFU — maps cleanly to software devices, and the quality OS carries the same records through change control, CAPA and training. Coverage analysis is especially useful for identifying clinical workflows where needs are undefined.
04How does the audit trail work?
Every create, update, delete, approve, and propagation event is recorded with actor, timestamp, and reason. Records are append-only and cannot be edited or deleted. Export to CSV for inspection.
05Is my data isolated from other organizations?
Yes. Each organization has an isolated tenant. Access is scoped at query time; no cross-tenant reads are possible. Enterprise deployments support single-tenant and on-premise options.
06Can I export data for regulatory submissions?
Yes. Product traceability exports as .xlsx from the product workspace. The audit trail exports as CSV for inspection and archival.
Make compliance move at the speed of innovation.
See both engines on your own use case — change control and CAPA on one side, living requirements traceability on the other. One platform, one audit trail.
ISO 13485 · 21 CFR Part 11 · EU MDR · UKCA