Stop relying on tribal R&D knowledge. We convert complex mechanical assemblies into validated, highly visual ISO 13485 work instructions, and we deliver structured, assessed training programmes to certify the engineers who use them.
If your field service instructions exist only in a lead engineer's head or as unvalidated CAD notes, you are failing ISO 13485 Clause 7.5. You cannot safely or legally outsource field repairs without verified, locked Risk Controls.
Under MDR and IVDR, service manuals are legally binding "Information for Safety." We process your documentation through a strict 5-Phase architecture.
We secure the Risk Management File (RMF), GA CAD (.STEP), and physical hardware. We reconcile the hardware against the CAD and engineer the core Safe-State isolation sequences (mains/pneumatic discharge).
Drafting the procedures using strict, verb-first imperative syntax. We apply ISO 3864 signal words (DANGER/WARNING/CAUTION) explicitly at the point of physical hazard.
Executing the authored drafts strictly on the bench to validate physical tool clearances, generating highly targeted vector line-art directly from the CAD data.
Final QARA review cycles to verify technical limits prior to formal ingestion into your Quality Management System (QMS) or Digital Service Portal.
Once your documentation is validated and ingested into your QMS, we can convert it into a structured training programme for your field engineers or third-party service partners. Training delivery is available as a standalone engagement independent of a full Technical Authoring project, provided a formally released service manual exists prior to engagement.
We build a Master Training Matrix directly from your released documentation, engineer binary pass/fail grading rubrics for all practical assessments, and deploy on-site to deliver and certify your engineer cohort. Every engineer assessed receives a signed training record suitable for ISO 13485 QMS ingestion.
Armchair Engineers. Schema Technical does not author blindly from CAD. The Client must provide one (1) physical, production-equivalent Device Under Test (DUT). If our team cannot physically prove the tooling clearance on the bench, we will not sign off the manual.
Documentation is scoped by its functional tier and regulatory safety profile.
The core architectural spine. Includes safety rules, required tooling matrices, and Preventative Maintenance (PPM) schedules.
Highly visual, modular replacement guides for standard Field Replaceable Units (e.g., fans, standard PCBs). Typically 2-4 pages.
Advanced instructions requiring proprietary alignment jigs, software calibration, or multi-stage teardowns.
Training Package: £1,500 fixed fee. On-site delivery: £1,200 per day plus expenses. Signed competency records included. Engineer count does not affect the package fee.