New One digit. 14 instruments. 5 countries. — How a firmware config error became an ISO 13485 evidence package.
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Quality management for regulated manufacturers

The QMS that knows what a failed calibration
means for your products.

When an instrument fails its calibration, CycleQA automatically identifies every product it qualified, every open non-conformance on those products, and every customer field report that may be related. In 30 seconds. Not half a day.

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No credit card. No commitment. 3 months free for pilot partners.

Built for
ISO 9001 IEC 60945 DNV / type-approval IATF 16949 ISO 13485 FDA 21 CFR Part 11
The problem

Your organisation already has the knowledge
it needs to run quality well.

It just has nowhere to live. And when it can't flow, the audit stress builds, the spreadsheets multiply, and the people who should be building products spend their time managing paperwork instead.

"A calibration certificate tells you an instrument was in tolerance on a given date. It tells you nothing about which products were qualified using it — or what happens to your quality chain if it later drifted."
01
Calibration and quality records don't talk to each other Instrument status and product quality status live in separate systems that were never designed to connect them. That's not a process problem. That's an architecture problem.
02
Traceability lives in the QA manager's head The field engineer who spotted the anomaly. The test engineer who knows which instrument was used. Knowledge that exists — but can't find its destination.
03
Compliance has become a cost that displaces engineering New reporting requirements, supply chain obligations, sustainability documentation — for an SME, each new requirement competes directly with the engineering talent that makes the product worth selling.
Why it matters now

A well-designed QMS changes
the equation.

Compliance becomes a natural output of work that was already happening — not a parallel job for a dedicated headcount. The experienced engineer stays where they belong. The QA manager gets leverage, not more paperwork.

For regulated SMEs navigating an increasingly demanding environment, this is not an abstract benefit. It is the difference between a quality system that works for you and one that works against you.

½ day
Average time a QA manager spends figuring out which products were affected when an instrument fails calibration — without CycleQA.
30 sec
Time to the same answer with CycleQA's calibration consequence chain. Automatic. No spreadsheet archaeology.
1–2 wk
Typical audit preparation time at an ISO 9001 SME today. CycleQA users pull an audit-ready summary in under 5 minutes.
How it works

One system. Every connection already made.

admin.cycleqa.com/calibration.html
Who it's for

Built for regulated manufacturers with 20–200 people.

Maritime electronics. Industrial systems. Automotive electronics. Medical devices. Anyone managing quality under ISO 9001, IEC standards, or type-approval requirements — and currently doing it in spreadsheets or a system never designed for your industry.

QA manager

Audit-ready in 30 seconds. No more spreadsheet archaeology before every survey. The traceability chain is already there.

Test engineer

Every instrument linked to the products it qualifies. Calibration status visible before you run the test, not after the surveyor asks.

Field engineer

Submit field reports from site in 2 minutes. Works offline. Already linked to the product and the open NCR when you get back online.

Inspector

Structured incoming inspection workflows. Findings linked directly to supplier records and open non-conformances.

Engineering manager

Know your calibration risk exposure before the type-approval campaign begins. No surprises during the test.

CEO / general manager

Quality runs without being a cost centre that competes with engineering. Your QA manager handles twice the compliance load with the same headcount.

and -->
Case study

One digit. Fourteen instruments.
Five countries.

A fictional medtech company — illustrating how CycleQA connects a field complaint to root cause to standard compliance. Every record shown here exists in a live CycleQA demo database.

Nov 2025
Incoming inspection
Reference artifact reads +0.048D — inside ±0.05D limit, at 96% of it. Accepted. Recorded.
Dec 2025
Vague field report
No serial number. No firmware version. No data. A WhatsApp voice message, effectively.
Jan 2026
Formal complaint — Munich
+0.12D systematic offset confirmed via structured wizard report. Firmware v2.4.1 flagged.
Feb 2026
Second report — offline, Eindhoven
Submitted from a motorway rest stop. Synced when network restored. Two countries, same firmware, same offset.
8 days later
Root cause confirmed
Config file: refractive index 1.3385 instead of the ISO 11979-2 measurement medium specification. One digit. Introduced by a contractor. Not caught in code review.
Apr 2026
All 14 sites resolved
Firmware v2.4.2 validated: +0.003D deviation. Field campaign complete. FSCA filed with Notified Body.
Nov 2026
ISO 13485 certificate
The incident became the evidence package. The QMS had recorded everything — including the borderline inspection from three months before anyone noticed the problem.
1.3385 in the firmware
1.3375 ISO 11979-2 measurement medium
Δn = 0.001  ·  systematic offset +0.12D across all IOL power ranges
📋 Field report
→
🔴 NCR + 8D
→
⚠ Risk register
→
📖 Standard clause
→
✅ Cal record
The auditor's traceability question — from customer complaint to corrective firmware to standard compliance — was four clicks. No spreadsheet archaeology. No emergency documentation sprint the week before the survey.
Download case study
PDF · 6 slides · OptiLens story
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Mobile-first

Quality from anywhere.
In seconds.

Every CycleQA module runs in any mobile browser — no app installation required. Open a secure link, scan a QR code, file a structured field report offline. The record is there when the auditor asks.

  • PWA — open admin.cycleqa.com in any browser, add to home screen
  • Offline-first — field reports queue locally, sync automatically
  • Secure token links — field engineers reach records directly from HQ notifications
  • Night & Day mode — ship bridges, labs, offices, outdoors
  • JWT auth · EU servers · full audit log — every action traceable
See all modules on mobile →
Pilot programme

We're building this with you,
not at you.

MH
I've spent the last period developing a QMS built around one belief: that quality improves when the whole organisation can participate in it, and that compliance should be a byproduct of good work — not a parallel job.

The result is a working platform, already online, designed for the workflows that actually exist. We're not public yet. We're looking for a small group of regulated manufacturers across Europe to test it properly — not as a commercial exercise, but to make sure it works across the full spectrum of real quality events before we open further.

If this problem is familiar from your own organisation, I'd genuinely welcome a conversation.
Markus Hein · Founder, CycleQA (under etablering) · Moss, Norway

3-month pilot. Full system. No cost.

  • All modules from day one — calibration, NCR, field reports, inspections, risks, standards
  • Dedicated onboarding: your equipment list, your roles, your real data
  • Direct access to the founder — not a helpdesk ticket
  • Your data, full PostgreSQL export, at any time — no lock-in
  • Genuine influence over what gets built next
Apply for the pilot ↗ Connect on LinkedIn Connect with Markus on LinkedIn

Less than one day of a senior engineer's time per month, when pricing begins.