FSH-DOCUMENTATION
Technical Documentation
Audit-ready documentation for machinery, plants and medical devices. Clear for operators, maintenance staff and auditors, revision-proof and delivered on time.
Available individually or as one continuous chain — from a blank page to the signed declaration of conformity.
Complete to DIN EN IEC/IEEE 82079-1 and DIN EN ISO 20607, covering every life-cycle phase, in the language of the destination country — including spare-parts catalogues and online help.
To DIN EN ISO 12100, ISO 13849-1/-2 and IEC 62061, including reasonably foreseeable misuse — the chapter most often missing in practice.
Technical file, declaration of conformity or incorporation, marking — under the Machinery Regulation (EU) 2023/1230 or Directive 2006/42/EC, depending on the applicable date; EMC, low voltage and pressure equipment where the project requires.
Document management in large projects: master document list, versioning and revision status, RACI and review matrix, supplier control, acceptance records — also as a role within your project team.
Technical documentation to Annex II/III, instructions for use, labelling and UDI, risk management to ISO 14971, usability to IEC 62366, clinical evaluation and study preparation.
Hazard assessments under the German BetrSichV, explosion protection document, operating instructions to TRGS 555, inspection registers — and setting up authoring systems such as Schema ST4 with standardisation and modularisation.
Our tool breaks a document set down into check points, backs every deviation with the passage and the standard that requires it, and estimates the rework in hours. You receive an inspection report for the decision and a technical report for the rework.
The standard requires information for every phase — not just normal operation. That is exactly where the gaps appear that become expensive later.
Clarify goal, standards, audience and language. You send what you have — incomplete is the norm.
Existing documents are checked against standards and legal sources; for new documents, an outline plus one sample chapter for approval.
Findings sorted by severity with a measure and effort per item — or writing and revision with reviews and correction loops.
Source files and PDF, integration into your DMS or authoring system on request. Followed by 30 days of fine-tuning, included.
We do not name clients without their consent. What the project covered and what came out of it — that we do.
10,000+ documents reviewed, classified and migrated to the DMS; operating manuals updated to the new plant status in line with the standards.
Existing documentation reviewed and assessed, standards and CE requirements secured, multilingual authoring workflow set up.
ISO/IEC-compliant documentation of the company-wide network infrastructure, developed with IT, operations and service.
Automotive mechanic, master craftsman (1999), a spell in engine prototype construction in Affalterbach, tekom qualification in technical communication. Today we deliver clear, auditable documentation for industry and MedTech — with more than 15 years of experience in energy, machinery and plant engineering, MedTech and defence.
Core team plus a proven network of experts (DE/EN/UKR/RU) for regulated environments: energy, plant engineering, medical technology.
Briefly describe your document or your project. You will hear back within 24 hours with the three most striking points — free of charge. We then agree with you on how to hand over your documents; on request with a 30-minute kick-off on goal, standards, audience and language.
