Skip to content
Asset & Compliance Tracker

Medical devices & surgical implants

Production and test equipment under ISO 13485 and EU MDR, tracked alongside the registrations and notified-body certificates that lapse on a calendar date — and the evidence that each one was current when the product shipped.

Ships today as the medical-devices pack, version 1ISO 13485 · EU MDR · FDA QSR

Document type
Industry pack
Document
ACT-WEB

What the pack gives you on day one.

Production and test equipment under ISO 13485, EU MDR and FDA QSR, with the registrations and notified-body certificates that lapse on a calendar date. Everything below is seeded into your organisation when you adopt the pack, and every row of it is yours from that moment: rename it, reorder it, delete it, add to it. Upgrading the pack later never overwrites something you have edited.

Devices you put in the register

Sterilizer
Autoclaves and sterilisation equipment whose validation expires.
Inspection gauge
Gauges and fixtures used to accept or reject product.
Test equipment
Equipment producing measurements that support a release decision.
Production equipment
Machines in the manufacturing process.
Cold storage
Freezers and refrigerated stores with monitored ranges.
Cleanroom system
HVAC, laminar flow, and particle-controlled environments.

Fields your sector needs

Not hardcoded into the product for everyone — defined by the pack, validated on every write, and filterable and exportable like any built-in field.

UDI-DIText
Unique Device Identifier — device identifier portion.
Risk classOne of a list
Class I · Class IIa · Class IIb · Class III
Validation stateOne of a list
IQ complete · OQ complete · PQ complete · Revalidation due

Your words, not ours

No screen in the product hardcodes a noun. The pack renames these, and the rest keep the neutral word.

  • assetDevices
  • entitlementCertifications
  • service_eventService records

What expires, and how early you hear about it.

These are the real warning ladders, not an illustration. Each one is set from how long that renewal actually takes — a certificate an authority re-inspects opens months ahead, because a thirty-day reminder would already be too late. The first rung is when the work has to start; a final 1 means it stops work the day it lapses.

Certifications the Medical devices & surgical implants pack seeds, with their default warning thresholds
CertificationWhy it is on the ladderWarns at
Device registrationRegistration with a competent authority. Renewal is a process, not a click.2701809030days before
Notified body certificateRecertification audits are booked months ahead.3651809030days before
Sterilisation validation—12060307days before
Calibration certificate—603071days before
Quality system certificateISO 13485 and equivalent scheme certificates.1809030days before
Supplier qualification—9030days before

Held against

Tag an obligation with the standard it satisfies, and the coverage report counts them — including the ones mapped to no framework at all, which is the number an auditor asks about.

  • ISO 13485 · ISO
  • EU MDR 2017/745 · European Commission
  • FDA 21 CFR 820 · US Food and Drug Administration
  • ISO 14971 · ISO

Views already drawn

Filters your sector asks for weekly, waiting above the register on the first day. They are ordinary saved views: change the columns, delete the ones you do not want, save your own.

  • Class III devices
  • Sterilisation equipment

The question the inspection opens on.

“Show me the calibration record for the gauge that accepted this batch.”

— what an auditor in this sector asks first

The auditor export answers it in one action: the device, every obligation on it, every plan, every service event, every filed document and the full change history — assembled in a single consistent read, so no two sections of the file can disagree. Two exports of an unchanged record are byte-for-byte identical.

  • Append-only history. Every change lands in an event log in the same transaction as the change. No role holds an update or delete grant on that table.

  • Certificates listed, with their evidence. Documents filed against the obligations and the service events are in the export too — the calibration certificate lives on the service event, and that is the one you will be asked for.

  • Readable by everyone on the team. Quality, finance and an external auditor given a seat can all run it. The people who most need the export are exactly the ones a viewer role would have blocked.

The dashboard on any Monday morning: what has already lapsed, what lapses this week, and what needs starting now to land on time.

Northfield LabsRegisterSample data
Overdue
03
Due this week
02
Next 30 days
06
Renewals to start
06
Failed sends
00
Sample obligations from a fictional organisation, resolved against an observation date the visitor controls. Every row is one record in the register — an obligation, the asset it sits on, and the person accountable for it.
ObligationStatus
Sterilisation validation8 Apr3d overdue
Storage permit15 Aprin 4d
Calibration certificate17 Aprin 6d
ISO 13485 certificate4 Julopen · 84d
Service contract25 Aprcancel in 14d
Pressure vessel inspection3 Apr8d overdue
Radiation source licence12 Mayopen · 31d
Torque wrench calibration20 Apropen · 9d
Notified-body surveillance6 Junopen · 56d
Cleanroom classification2 Mayopen · 21d
Forklift operator ticket10 Apr1d overdue
Balance verification8 Mayin 27d

Bring us your medical devices spreadsheet.

The first session is the import: a column mapper, a dry run that shows exactly what will be created, a per-row error report numbered to match your file, and an undo for the whole batch in one action. Getting five hundred rows in on day one is the point, not a later project.

Programme
Pilot
Places
Limited
Reply
Every enquiry
Request a pilot

Tell us your sector and roughly how many assets you track. We reply to every one.