QOPR builds the documentation your product legally requires, from your first user requirement to your final verification record, and keeps every link connected so a small edit stays a small edit. Built for medical devices, CE-marked hardware, functional safety, and any product where traceability is the standard.
| User Req. | Product Requirement | Sub-Req. | Verification |
|---|---|---|---|
| IPP-UR-003 | IPP-PR-014 Basal rate programmable 0.05–5.0 U/hr in 0.05 increments. |
IPP-SW-022 | IPP-VER-031 |
| IPP-UR-003 | IPP-PR-015 Occlusion detected and alarmed within 30 minutes. |
IPP-HW-009 | IPP-VER-033 |
| IPP-UR-007 | IPP-PR-021 Adhesive patch maintains seal for 72 hours of wear. |
IPP-HW-014 | IPP-VAL-008 |
In most industries, a good product is enough. In regulated industries, that's not enough on its own. Regulators, standards bodies, and customers require documented evidence that you defined what your product needed to do, designed it to meet those needs, and proved it works as intended, before it ever ships, gets certified, or reaches an end user.
In medical devices, that documentation package is called a Design History File (DHF), required under FDA 21 CFR Part 820 and ISO 13485. In other industries it goes by different names: a Technical File for CE marking, a Safety Case for IEC 61508, a Design Dossier for automotive. The structure is the same. The consequence of not having it is the same: your product can't be cleared, certified, or sold.
Most first-time developers discover the documentation requirement somewhere between "great prototype" and "we need to submit." By that point, rebuilding months of undocumented design decisions is painful. Starting early changes everything.
The teams that struggle with audits are the ones who tried to reconstruct their design history after the fact. The ones who pass built it alongside the product.
A Design History File is the complete record of how your product was designed. It exists to answer the question regulators will eventually ask: "How do you know this product does what you say it does?" In medical devices it's called a DHF. In other industries the same concept appears as a Technical File, Safety Case, or Design Dossier. Whatever it's called, a complete record typically includes:
What problems does your product solve? Who uses it, and under what conditions? The needs your product must meet, written down before you design anything.
How will your product meet those user needs? Specific, testable design inputs: dimensions, performance specs, software behaviors, material properties.
The actual design: drawings, schematics, software architecture, material specs. The things you build from.
What could go wrong? How likely, and how severe? Regulatory standards require a structured hazard analysis (often called a DFMEA) that links risks back to your requirements.
Proof that your design outputs meet your product requirements: test data, inspection results, and analysis reports, linked to the specific requirements they verify.
Proof that your finished product actually meets your user's needs in real-world conditions. The end of the traceability chain.
QOPR gives each of these a structured home, and keeps them connected. Change one thing, and every linked record reflects it.
The hardest part of regulated documentation isn't writing any single document. It's keeping all of them connected as your design evolves. QOPR models the connections between every element, so your trace matrix stays current without a separate documentation effort.
Edit a product requirement and your trace matrix updates instantly. Change a verification record and every requirement linked to it reflects the update. QOPR pulls every edit through the whole connected structure, so a one-line change never becomes a documentation project.
| User Req. | Product Requirement | Sub-Req. | Verification |
|---|---|---|---|
| IPP-UR-003 | IPP-PR-014 Basal rate programmable 0.05–5.0 U/hr. | IPP-SW-022 | IPP-VER-031 |
| IPP-UR-003 | IPP-PR-015 Occlusion alarmed within 30 minutes. | IPP-HW-009 | IPP-VER-033 |
| IPP-UR-007 | IPP-PR-021 Adhesive maintains seal for 72 hours. | IPP-HW-014 | IPP-VAL-008 |
| IPP-UR-011 | IPP-PR-027 Bolus delivery accurate to ±5% of set dose. | IPP-SW-031 | – pending – |
Capture user requirements, product requirements, and sub-requirements with structured IDs your auditors recognize.
Connect requirements to design outputs, hazards, and verification records as your design matures. QOPR enforces the links, not a convention in a spreadsheet no one updates.
Generate a complete trace matrix at any time showing every requirement, what it links to, and whether it's been verified. Forward and backward. Always current.
Open any requirement and link it to the user needs it satisfies, the sub-requirements it breaks down into, and the records that verify it, from one panel, with live search. No copying IDs between spreadsheet tabs.
Because links are stored as real relationships and not text in a cell, your trace matrix, coverage gaps, and Word exports all stay in sync automatically.
There's nothing wrong with starting in Excel or a shared doc. Everyone does. But as your device design evolves and your DHF grows, the cracks appear: links break, versions diverge, and nobody's sure which trace matrix is current.
And if you try to build something more structured, the setup time alone becomes a project:
| Spreadsheets & Docs | General tools (Jira, Confluence) | QOPR | |
|---|---|---|---|
| Structured requirement IDs | |||
| Native traceability links | with plugins | ||
| Auto-generated trace matrix | |||
| Exportable finished documents | |||
| Built for regulated products | |||
| Setup time for compliant use | 40+ hours | Weeks + $5–15k | Minutes |
| Starting cost | Free software, your time | $8–15/user/mo + setup | $29/mo flat |
QOPR isn't a workaround. It's what a requirements system looks like when it's designed for regulated products from the start.
Requirements traceability isn't unique to medical devices. Across regulated industries, the same challenge exists: documented evidence connecting what you designed, why you designed it that way, and how you verified it. QOPR is built for that problem, whatever the standard requires.
FDA 21 CFR Part 820, ISO 13485, IEC 62304 (software), ISO 14971 (risk). The Design History File is the gold standard for requirements traceability. QOPR is built around it.
Machinery Directive, Low Voltage Directive, Radio Equipment Directive. A CE technical file requires the same structure as a DHF: intended use, risk analysis, design specs, and test evidence.
IEC 61508, ISO 13849, EN 50128. Functional safety standards explicitly require requirements traceability from safety functions down through design and verification.
ISO 26262, ASPICE, IATF 16949. Tier 2 and 3 suppliers face the same documentation burden as OEMs but rarely have the budget for enterprise ASPICE tools. QOPR gives them a structured start.
IEC 62304, EU AI Act. Software as a Medical Device and high-risk AI systems require requirements traceability from intended use through architecture and testing.
AS9100, DO-178C, DO-254. Small aerospace suppliers and defense subcontractors are held to the same traceability standards as primes, without the same tooling budget. QOPR fills that gap.
One flat price for your entire organization: no per-seat fees, no feature tiers, no surprises. Everything you need to build and maintain a complete design history from day one.
Early access pricing. No commitment required.
ISO 13485, IEC 61508, ISO 26262, and similar standards all require documented evidence at every stage of product development, from the first definition of user needs through risk analysis, design, and final verification. QOPR maps directly to that lifecycle, so your documentation structure matches what regulators expect.
Captured as User Requirements: what your product must do and for whom.
DFMEA-style hazard entries linked to requirements: what could go wrong and how you address it.
Specific, testable design inputs: how your product meets those needs.
Records capturing design decisions: drawings, specs, software architecture.
Test protocols and records linked back to requirements. Proof it works.
When a regulator asks for your design history, QOPR generates the trace. You just print it.
A common misconception is that proper design documentation requires an enterprise Quality Management System. It doesn't. What it requires is that your records exist, are organized, and show the links between requirements and evidence. QOPR handles all of that.
When you're ready, QOPR exports your trace matrix, requirement specifications, verification summaries, and hazard analysis as finished, formatted documents. You can attach them to a regulatory submission, upload them to any QMS as records, print them for a paper file, or hand them directly to an auditor. The structure regulators expect is already built in.
If you do use a QMS, QOPR fits alongside it. Think of QOPR as where your requirements live and your traceability is maintained, and your QMS as the filing cabinet. They don't compete.
Generate finished documents whenever you need them: before an audit, at a design review milestone, or when filing a submission. No reformatting, no manual assembly.
Bring QOPR exports into any QMS platform or a shared drive. Or skip the QMS entirely and file the documents in a binder. The records are yours in a format that works anywhere.
Many early-stage teams still keep paper records. QOPR works the same way: build and trace your requirements digitally, then print the outputs and file them. You get the structure without the overhead.
QOPR is in active development and onboarding early teams. If you're building a regulated product and want documentation that grows with your design instead of catching up to it, we'd love to have you in.
Built for regulated product development. No commitment required.