Medical device measurement control

Confidence in the equipment behind the work.

Connect equipment control across development, production and quality operations, with the method, evidence and review history behind every calibration result.

Electronic records
Calibration event record showing its guided work plan and technical evidence status
A calibration record with its operational and technical context connected.

Across the operating lifecycle

A consistent evidence path wherever equipment affects quality

  1. 01

    Development

    Control laboratory and engineering equipment while methods and products evolve.

  2. 02

    Production

    Keep recurring calibration requirements and due work visible across sites.

  3. 03

    Quality control

    Guide controlled work and preserve the technical basis for acceptance decisions.

  4. 04

    Investigation

    Connect failed calibration to impact assessment, containment and corrective action.

  5. 05

    Audit review

    Present scoped equipment and calibration evidence with its provenance intact.

Controlled methods

Make the procedure part of the record

Start with a readable controlled method, reveal advanced evidence controls only where they apply, and hand the completed revision to an independent reviewer before use.

Explore procedure guides
Calibration procedure authoring workspace with controlled ordered steps
A pre-review checklist keeps each controlled revision ready for an independent decision.
Conformity decision evidence showing tolerance, uncertainty and acceptance limits
The result retains the controlled reasoning used to reach it.

Explain the acceptance decision

Preserve why it passed or failed

Connect measured error, tolerance, uncertainty, guard band and boundary policy. Approved evidence keeps the exact uncertainty budget and decision-rule revisions used at the time.

Nonconforming work

Follow the impact beyond the calibration bench

Structured investigations record impact, containment, root cause, disposition and corrective action against the result that triggered review, preserving a coherent quality history.

Out-of-tolerance investigation with impact and corrective-action fields
Investigation evidence remains connected to the affected equipment and calibration.

Records with provenance

Keep history without overwriting it

Organisation-scoped access

Permissions and memberships control who can perform, review, approve and export work.

Revision history

Controlled records use revision, supersession and append-only audit history rather than silent replacement.

Certificate evidence

Retain certificate metadata and replacement history beside calibration events.

Scoped dossiers

Freeze selected sites, dates and evidence into a reviewable audit revision.

Connect the equipment record to the quality story.

See how Metra turns recurring calibration work into structured, reviewable evidence.

Features

Obsidian Metra does not confer FDA, MDR or ISO 13485 compliance, validate customer processes, or make product-release decisions. Your organisation remains responsible for validation, regulatory obligations and professional judgement.