Regulatory & Compliance
Technical Writing.
We create, organize, and maintain highly precise documentation for the medtech and pharmaceutical industries—from MDR-compliant instructions for use (IFU) to validation-ready GMP standard operating procedures (SOPs).
Why do approvals often fail because of technical documentation?
With the entry into force of the MDR and IVDR, technical documentation has evolved from a set of specifications into a critical bottleneck in the approval process:
- Technical dossiers are often not fully aligned with clinical evaluation and risk management.
- Instructions for use (IFU) often do not comply with the strict EN ISO 15223 standard or are difficult for users to understand.
- SOPs in complex GMP environments lack procedural clarity, which immediately leads to non-conformities during inspections.
- In-house specialist teams simply do not have the time to draft hundreds of pages of documentation with the required regulatory precision.
Is your technical documentation written so thoroughly that an external auditor can’t find any logical inconsistencies?
Our technical writing services.
We translate complex technical and regulatory requirements into audit-ready, structured documents.
Technical Documentation (MDR/IVDR)
Preparation and in-depth review of complete technical dossiers in accordance with MDR Annexes II and III. We ensure consistency in clinical data and risk analyses.
Instructions for Use (IFU)
We draft IFUs that comply with ISO 15223 and usability standards (IEC 62366). We manage multilingual IFU packages and labeling requirements for international markets.
Regulatory SOPs & QMS Documents
Development of precise, operational SOPs for GMP production areas, QMS processes, and clinical trials. We prioritize clear writing structures and unambiguous terminology.
Document Management & Lifecycle
Consulting on establishing a robust document lifecycle (creation, approval, revision). Support with migration to electronic systems (eQMS).
Frequently Asked Questions About Technical Writing.
What is the difference between technical writing and medical writing?
Technical writing focuses on technical product documentation (dossiers, IFUs, manufacturing SOPs, specifications). Medical writing deals exclusively with clinical and medical documents (study protocols, investigator brochures).
In how many languages must the IFU be available?
In Europe, IFUs must be available in the official language of the country where the product is marketed—which means up to 24 languages in the EU. For certain products, an electronic IFU (eIFU) may be sufficient.
How often do technical documents need to be updated?
Always context-specific: in response to product changes, findings from post-market surveillance (PMS), new regulatory requirements, or new clinical data. The MDR requires that the document be kept up to date at all times ("living document").
Do you also write complex GMP SOPs for pharmaceutical manufacturing?
Yes, absolutely. We draft and revise standard operating procedures for pharmaceutical manufacturing, quality assurance, and validation based on the EU GMP guidelines and FDA cGMP.
Additional services related to documentation.
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